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A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.

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ClinicalTrials.gov Identifier: NCT00603278
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : August 12, 2013
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: GW685698X
Drug: placebo
Enrollment 622
Recruitment Details  
Pre-assignment Details Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline safety evaluations and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. 1406 par. were screened, and 622 par. were randomized, out of which 615 par. received at least one dose of study treatment.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description Participants received placebo once daily (OD) in the evening from the novel dry powder inhaler (NDPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study. Participants received GW685698X 100 micrograms (µg) OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Period Title: Overall Study
Started 107 105 101 103 99 100
Completed 66 88 87 92 86 81
Not Completed 41 17 14 11 13 19
Reason Not Completed
Lack of Efficacy             35             10             11             8             7             14
Adverse Event             0             3             1             0             2             1
Withdrawal by Subject             2             3             1             2             1             2
Protocol Violation             3             0             1             1             0             1
Physician Decision             0             1             0             0             2             1
Lost to Follow-up             1             0             0             0             1             0
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID Total
Hide Arm/Group Description Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study. Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 107 105 101 103 99 100 615
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 105 participants 101 participants 103 participants 99 participants 100 participants 615 participants
39.1  (16.19) 38.3  (16.76) 38.8  (15.97) 39.9  (15.57) 40.7  (15.87) 39.8  (16.70) 39.4  (16.14)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 105 participants 101 participants 103 participants 99 participants 100 participants 615 participants
Female
74
  69.2%
72
  68.6%
63
  62.4%
67
  65.0%
64
  64.6%
62
  62.0%
402
  65.4%
Male
33
  30.8%
33
  31.4%
38
  37.6%
36
  35.0%
35
  35.4%
38
  38.0%
213
  34.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 107 participants 105 participants 101 participants 103 participants 99 participants 100 participants 615 participants
White 62 64 65 63 56 61 371
Central/South Asian Heritage (HER) 1 1 0 1 0 0 3
Japanese/East Asian HER/South East Asian HER 25 24 23 22 25 23 142
American Indian or Alaska Native 0 1 0 0 0 0 1
American Indian or Alaska Native & White 14 12 13 14 13 13 79
African American/African HER 5 2 0 2 4 3 16
African American/African Heritage & White 0 1 0 0 0 0 1
Native Hawaiian or other Pacific Islander 0 0 0 0 1 0 1
Missing 0 0 0 1 0 0 1
1.Primary Outcome
Title Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 106 102 101 102 97 99
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-0.065  (0.0395) 0.142  (0.0403) 0.173  (0.0404) 0.228  (0.0402) 0.215  (0.0414) 0.160  (0.0409)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW685698X 100 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.207
Confidence Interval (2-Sided) 95%
0.096 to 0.318
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW685698X 200 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.238
Confidence Interval (2-Sided) 95%
0.127 to 0.349
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW685698X 300 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.293
Confidence Interval (2-Sided) 95%
0.182 to 0.404
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW685698X 400 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.279
Confidence Interval (2-Sided) 95%
0.167 to 0.392
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, FP 250 µg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.225
Confidence Interval (2-Sided) 95%
0.114 to 0.337
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period
Hide Description PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.
Time Frame From Baseline up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 107 104 101 102 99 99
Least Squares Mean (Standard Error)
Unit of Measure: Liters per minute
-2.8  (3.54) 9.1  (3.60) 14.8  (3.65) 15.1  (3.62) 21.0  (3.70) 18.2  (3.69)
3.Secondary Outcome
Title Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period
Hide Description PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.
Time Frame From Baseline up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 107 104 101 102 99 99
Least Squares Mean (Standard Error)
Unit of Measure: Liters per minute
-4.7  (3.78) 15.6  (3.85) 16.0  (3.89) 25.5  (3.87) 26.0  (3.95) 25.1  (3.94)
4.Secondary Outcome
Title Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period
Hide Description Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.
Time Frame From Baseline up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 107 104 101 102 99 99
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of symptom-free 24-hr periods
17.1  (2.91) 21.3  (2.96) 19.4  (2.99) 24.1  (2.97) 28.0  (3.02) 30.4  (3.02)
5.Secondary Outcome
Title Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period
Hide Description The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hr period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of baseline, country, sex, age, and treatment group.
Time Frame From Baseline up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 107 104 101 102 99 99
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of rescue-free 24-hr periods
15.6  (3.02) 25.0  (3.07) 23.8  (3.12) 25.0  (3.10) 24.4  (3.15) 34.5  (3.15)
6.Secondary Outcome
Title Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
Hide Description The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.
Time Frame From the first dose of study medication up to Week 8/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 107 105 101 103 99 100
Measure Type: Number
Unit of Measure: Participants
35 10 11 8 7 14
7.Secondary Outcome
Title Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.
Time Frame From the first dose of study medication up to Week 8/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 107 105 101 103 99 100
Measure Type: Number
Unit of Measure: Participants
Any AE 32 43 33 41 35 42
Any SAE 0 0 0 1 1 0
8.Secondary Outcome
Title Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis
Hide Description A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed for the entire Treatment Period.
Time Frame From Baseline up to Week 8/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 107 105 101 103 99 100
Measure Type: Number
Unit of Measure: Participants
Clinical evidence 0 3 2 4 2 4
No clinical evidence 107 102 99 99 97 96
9.Secondary Outcome
Title Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 100 103 97 99 94 95
Mean (Standard Deviation)
Unit of Measure: Percentage
Basophils, BL, n=100, 103, 97, 99, 94, 95 0.33  (0.159) 0.32  (0.179) 0.35  (0.188) 0.31  (0.155) 0.33  (0.169) 0.34  (0.209)
Basophils,W8, n=63, 84, 82, 83, 81, 82 0.31  (0.182) 0.32  (0.191) 0.38  (0.227) 0.33  (0.165) 0.32  (0.203) 0.35  (0.190)
Eosinophils, BL, n=100, 103, 97, 99, 94, 95 4.48  (3.262) 4.05  (2.882) 4.05  (2.981) 4.17  (2.649) 4.20  (3.185) 4.66  (3.393)
Eosinophils, W8, n=63, 84, 82, 83, 81, 82 4.78  (4.107) 3.72  (2.518) 3.54  (2.556) 3.53  (2.671) 3.35  (3.063) 4.21  (3.290)
Lymphocytes, BL, n=100, 103, 97, 99, 94, 95 34.05  (9.683) 33.97  (8.817) 34.01  (9.214) 33.70  (8.380) 31.48  (9.075) 33.61  (9.032)
Lymphocytes, W8, n=63, 84, 82, 83, 81, 82 33.51  (8.261) 32.95  (8.183) 31.39  (8.668) 30.97  (8.711) 27.38  (7.585) 33.17  (7.607)
Monocytes, BL, n=100, 103, 97, 99, 94, 95 4.66  (1.674) 4.52  (2.128) 4.85  (1.939) 4.58  (1.994) 4.47  (1.954) 4.55  (2.190)
Monocytes, W8, n=63, 84, 82, 83, 81, 82 4.85  (1.798) 4.82  (3.006) 4.92  (2.324) 4.42  (1.833) 4.18  (2.176) 4.59  (2.436)
Total Neutrophils, BL, n=100, 103, 97, 99, 94, 95 56.53  (9.391) 58.17  (9.386) 59.75  (9.513) 60.72  (9.846) 64.75  (8.896) 57.61  (9.681)
10.Secondary Outcome
Title Hematocrit at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 102 104 96 99 93 95
Mean (Standard Deviation)
Unit of Measure: Proportion of 1
Hematocrit, BL, n=102, 104, 96, 99, 93, 95 0.42  (0.041) 0.43  (0.034) 0.42  (0.043) 0.42  (0.035) 0.42  (0.039) 0.42  (0.039)
Hematocrit, W8, n=62, 84, 82, 83, 81, 81 0.41  (0.037) 0.42  (0.039) 0.42  (0.043) 0.41  (0.038) 0.42  (0.046) 0.41  (0.055)
11.Secondary Outcome
Title Hemoglobin at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 102 104 96 99 93 95
Mean (Standard Deviation)
Unit of Measure: Grams per liter (G/L)
Hemoglobin, BL, n=102, 104, 96, 99, 93, 95 137.64  (13.911) 139.34  (11.908) 137.74  (14.028) 138.08  (11.707) 138.57  (13.393) 136.93  (14.139)
Hemoglobin, W8, n=62, 84, 82, 83, 81, 81 135.09  (12.043) 136.42  (13.342) 137.85  (13.772) 135.30  (12.360) 138.17  (15.050) 135.79  (18.663)
12.Secondary Outcome
Title Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 101 103 96 99 93 95
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter (GI/L)
Platelet count, BL, n=98, 103,93, 98, 89, 94 286.23  (57.383) 277.29  (64.358) 290.90  (98.801) 282.86  (70.086) 283.01  (58.915) 285.45  (69.220)
Platelet count, W8, n=60, 84, 80, 81, 80, 80 275.91  (53.705) 281.40  (66.449) 277.73  (71.595) 287.98  (67.053) 297.83  (76.271) 287.60  (87.009)
WBC, BL, n=101, 103, 96, 99, 93, 95 8.05  (2.310) 7.90  (2.110) 7.69  (2.086) 8.11  (2.332) 8.23  (2.027) 8.12  (2.141)
WBC, W8, n=62, 84, 82, 83, 81, 81 8.02  (1.991) 8.06  (1.894) 7.79  (2.066) 8.20  (1.936) 9.07  (2.054) 8.30  (3.119)
13.Secondary Outcome
Title Red Blood Cells (RBC) Count at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 102 104 96 99 93 95
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter (TI/L)
BL, n=102, 104, 96, 99, 93, 95 4.66  (0.439) 4.68  (0.385) 4.69  (0.539) 4.63  (0.442) 4.64  (0.395) 4.61  (0.412)
W8, n=62, 84, 82, 83, 81, 80 4.54  (0.483) 4.57  (0.447) 4.62  (0.513) 4.50  (0.458) 4.66  (0.526) 4.52  (0.426)
14.Secondary Outcome
Title Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 106 104 101 102 98 99
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
ALP, BL, n=106, 104, 101, 102, 98, 99 89.3  (58.42) 90.5  (61.69) 83.7  (56.68) 88.0  (74.76) 83.8  (40.51) 89.0  (57.83)
ALP, W8, n=65, 85, 84, 89, 83, 81 88.0  (57.32) 82.8  (44.87) 77.9  (40.64) 77.9  (37.21) 81.9  (40.05) 88.6  (53.16)
ALT, BL, n=106, 104, 101, 102, 98, 99 22.3  (21.25) 20.0  (14.75) 20.5  (15.44) 23.4  (15.65) 20.4  (12.70) 20.6  (15.83)
ALT, W8, n=65, 85, 85, 89, 83, 81 20.1  (14.37) 21.0  (14.01) 20.8  (11.68) 23.3  (16.73) 22.1  (18.46) 20.3  (14.92)
AST, BL, n=106, 103, 100, 102, 97, 99 25.2  (30.81) 20.8  (7.81) 24.8  (38.56) 22.7  (10.10) 21.2  (7.10) 21.4  (10.18)
AST, W8, n=65, 85, 85, 89, 83, 81 21.8  (8.77) 20.5  (7.50) 21.4  (8.42) 22.7  (12.58) 21.7  (8.87) 21.4  (8.51)
LD, BL, n=106, 103, 100, 102, 97, 99 173.2  (66.73) 167.1  (44.88) 173.8  (129.22) 169.0  (54.06) 168.6  (50.65) 167.1  (57.95)
LD, W8, n=65, 85, 85, 89, 83, 81 157.4  (37.93) 158.2  (29.31) 162.5  (35.17) 160.6  (30.45) 169.2  (31.91) 162.4  (35.39)
GGT, BL, n=106, 104, 101, 102, 98, 99 33.1  (54.48) 26.0  (20.33) 27.6  (21.53) 35.2  (38.16) 28.2  (18.36) 29.5  (27.60)
GGT, W8, n=65, 85, 85, 89, 83, 81 31.5  (44.86) 30.1  (41.05) 29.2  (31.63) 34.8  (39.40) 28.3  (23.69) 28.4  (24.14)
15.Secondary Outcome
Title Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 106 104 101 102 98 99
Mean (Standard Deviation)
Unit of Measure: Grams per liter (G/L)
Albumin,BL, n=106, 104, 101, 102, 98, 99 45.2  (3.43) 45.4  (3.12) 45.4  (3.16) 45.4  (2.71) 45.5  (2.62) 44.9  (2.86)
Albumin, W8, n=65, 85, 85, 89, 83, 81 44.0  (3.06) 44.7  (3.08) 45.1  (2.81) 44.6  (2.81) 45.3  (2.91) 44.5  (3.19)
Total protein, BL, n=106, 104, 101, 102, 98, 99 74.1  (5.03) 73.3  (4.16) 73.9  (4.40) 73.7  (4.42) 74.0  (4.37) 73.0  (4.26)
Total protein, W8, n=65, 85, 85, 89, 83, 81 72.0  (4.68) 72.4  (4.31) 73.3  (5.28) 72.5  (3.92) 73.9  (4.02) 72.8  (4.16)
16.Secondary Outcome
Title Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 106 104 101 102 98 99
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
Chloride, BL, n=106, 104, 101, 102, 98, 99 104.8  (3.06) 105.0  (2.61) 104.7  (3.15) 104.5  (2.34) 104.8  (3.00) 105.0  (2.41)
Chloride, W8, n=65, 85, 85, 89, 83, 81 104.8  (2.31) 104.3  (2.05) 104.3  (2.36) 104.4  (2.20) 104.0  (2.37) 104.4  (2.37)
Calcium, BL, n=106, 103, 100, 102, 97, 99 2.3  (0.12) 2.3  (0.12) 2.3  (0.12) 2.3  (0.10) 2.3  (0.12) 2.3  (0.11)
Calcium, W8, n=65, 85, 84, 89, 83, 81 2.3  (0.12) 2.3  (0.12) 2.3  (0.11) 2.3  (0.11) 2.3  (0.12) 2.3  (0.11)
CO2/BI, BL, n=106, 103, 100, 102, 97, 99 22.9  (2.12) 22.5  (2.67) 22.7  (2.40) 22.6  (2.58) 22.6  (2.24) 22.6  (2.15)
CO2/BI, W8, n=65, 85, 85, 89, 83, 81 22.4  (2.08) 22.5  (2.40) 22.8  (2.72) 23.1  (2.40) 22.8  (2.58) 22.9  (2.37)
Cholesterol, BL, n=106, 104, 101, 102, 98, 99 5.0  (1.09) 5.0  (1.21) 4.9  (1.07) 5.2  (1.13) 5.2  (1.16) 5.0  (1.12)
Cholesterol, W8, n=65, 85, 85, 89, 83, 81 4.9  (1.06) 5.0  (1.19) 4.9  (1.03) 5.1  (1.08) 5.1  (1.11) 4.9  (1.05)
Glucose, BL, n=106, 103, 100, 102, 98, 99 5.2  (0.94) 5.4  (1.95) 5.1  (0.70) 5.2  (0.84) 5.5  (2.18) 5.5  (1.88)
Glucose, W8, n=65, 85, 85, 89, 83, 81 5.0  (0.73) 5.2  (1.66) 5.1  (1.04) 5.2  (1.06) 5.0  (1.46) 5.3  (1.85)
PI, BL, n=106, 104, 101, 102, 98, 99 1.2  (0.20) 1.2  (0.22) 1.2  (0.33) 1.2  (0.19) 1.2  (0.19) 1.1  (0.22)
PI, W8, n=65, 85, 85, 89, 83, 81 1.3  (0.21) 1.3  (0.17) 1.2  (0.18) 1.2  (0.17) 1.3  (0.26) 1.3  (0.19)
Potassium, BL, n=106, 103, 100, 102, 97, 98 4.2  (0.41) 4.1  (0.45) 4.1  (0.44) 4.2  (0.46) 4.2  (0.38) 4.1  (0.41)
Potassium, W8, n=65, 85, 84, 89, 83, 81 4.2  (0.64) 4.2  (0.53) 4.3  (0.63) 4.2  (0.44) 4.3  (0.66) 4.2  (0.34)
Sodium, BL, n=106, 104, 101, 102, 98, 99 140.7  (3.38) 140.6  (1.91) 141.0  (3.13) 140.3  (2.07) 140.7  (2.85) 140.5  (1.76)
Sodium, W8, n=65, 85, 85, 89, 83, 81 139.9  (2.11) 140.0  (1.95) 140.3  (2.05) 140.5  (2.15) 140.3  (2.23) 140.2  (1.80)
BUN, BL, n=106, 104, 101, 102, 98, 99 5.3  (1.87) 5.1  (2.07) 5.1  (1.90) 4.9  (1.61) 5.2  (2.20) 5.3  (1.78)
BUN, W8, n=65, 85, 85, 89, 83, 81 5.2  (1.42) 4.9  (1.47) 5.0  (1.61) 5.0  (1.68) 4.8  (1.60) 5.2  (1.64)
17.Secondary Outcome
Title Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of DBIL, TBIL, uric acid and creatinine at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 106 104 101 102 98 99
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter (µmol/L)
DBIL, BL, n=106, 103, 100, 101, 98, 98 2.1  (1.23) 2.0  (1.30) 1.9  (1.09) 1.9  (1.09) 2.1  (0.97) 1.8  (0.90)
DBIL, W8, n=65, 65, 85, 89, 83, 81 1.8  (0.97) 2.0  (1.09) 1.9  (0.88) 1.9  (0.88) 1.8  (0.93) 1.7  (0.75)
TBIL, BL, n=106, 104, 101, 102, 98, 99 10.2  (5.39) 10.6  (6.11) 9.4  (5.20) 9.3  (4.65) 9.7  (5.48) 8.9  (4.02)
TBIL, W8, n=65, 85, 85, 89, 83, 81 8.5  (4.38) 9.6  (6.13) 9.2  (4.93) 8.8  (4.14) 9.2  (4.08) 8.4  (3.03)
Uric acid, BL, n=106, 104, 101, 102, 98, 99 326.7  (93.33) 323.2  (83.60) 319.4  (94.90) 326.7  (95.36) 323.9  (82.30) 312.7  (85.72)
Uric acid, W8, n=65, 85, 85, 89, 83, 81 308.8  (89.18) 318.3  (84.85) 319.7  (93.76) 314.4  (94.26) 321.1  (83.68) 311.4  (90.62)
Creatinine, BL, n=106, 104, 101, 102, 98, 99 77.9  (14.57) 77.9  (18.60) 77.8  (16.50) 75.9  (15.04) 75.9  (18.24) 77.7  (15.77)
Creatinine, W8, n=65, 85, 85, 89, 83, 81 74.4  (15.58) 74.6  (14.95) 78.5  (16.79) 76.9  (15.97) 76.2  (15.18) 77.2  (16.59)
18.Secondary Outcome
Title Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
Hide Description Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (WD). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 102 101 98 99 94 97
Measure Type: Number
Unit of Measure: Participants
UOB, Neg, BL, n=102, 101, 98, 99, 94, 95 96 91 85 90 81 91
UOB, Trace, BL, n=102, 101, 98, 99, 94, 97 4 1 3 4 8 2
UOB, 1+, BL, n=102, 101, 98, 99, 94, 97 1 4 6 1 1 1
UOB, 2+, BL, n=102, 101, 98, 99, 94, 97 0 1 1 0 0 1
UOB, 3+, BL, n=102, 101, 98, 99, 94, 97 1 4 3 4 4 2
UOB, Neg, W8, n=63, 85, 84, 82, 82, 82 56 77 77 73 73 72
UOB, Trace, W8, n=63, 85, 84, 82, 82, 82 4 3 2 3 2 4
UOB, 1+, W8, n=63, 85, 84, 82, 82, 82 0 2 1 1 3 1
UOB, 2+, W8, n=63, 85, 84, 82, 82, 82 1 1 2 1 3 1
UOB, 3+, W8, n=63, 85, 84, 82, 82, 82 2 2 2 4 1 4
UOB, Neg, WD, n=9, 4, 1, 2, 3, 7 9 4 1 2 3 6
UOB, 2+, WD, n=9, 4, 1, 2, 3, 7 0 0 0 0 0 1
UG, Neg, BL, n=102, 101, 98, 99, 94, 97 100 98 98 98 91 94
UG, Trace, BL, n=102, 101, 98, 99, 94, 97 1 1 0 0 0 0
UG, Trace or 1/10 G/DL, BL, n=102, 101,98,99,94,97 1 0 0 0 0 1
UG, 1+ or 1/3 G/DL, BL, n=102, 101, 98, 99, 94, 97 0 0 0 1 1 1
UG, 3+ or 1 G/DL, BL, n=102, 101, 98, 99, 94, 97 0 2 0 0 2 1
UG, Neg,W8, n=63, 85, 84, 82, 82, 82 62 83 83 81 82 80
UG, Trace, W8, n=63, 85, 84, 82, 82, 82 0 0 1 1 0 0
UG, 1+ or 1/4 G/DL, W8, n=63, 85, 84, 82, 82, 82 1 0 0 0 0 0
UG, 3+ or 1 G/DL, W8, n=63, 85, 84, 82, 82, 82 0 2 0 0 0 2
UG, Neg, WD, n=9, 4, 1, 2, 3, 7 9 4 1 2 3 7
UK, Neg, BL, n=102, 101, 98, 99, 94, 97 97 96 96 96 90 94
UK, Trace, BL, n=102, 101, 98, 99, 94, 97 5 2 2 3 4 1
UK, 1+, BL, n=102, 101, 98, 99, 94, 97 0 2 0 0 0 2
UK, 2+, BL, n=102, 101, 98, 99, 94, 97 0 1 0 0 0 0
UK, Neg, W8, n=63, 85, 84, 82, 82, 82 61 80 81 78 75 80
UK, Trace, W8, n=63, 85, 84, 82, 82, 82 2 5 2 4 7 2
UK, 1+, W8, n=63, 85, 84, 82, 82, 82 0 0 1 0 0 0
UK, Neg, WD, n=9, 4, 1, 2, 3, 7 9 4 1 2 3 7
UP, Neg, BL, n=102, 101, 98, 99, 94, 97 76 78 77 78 70 75
UP, Trace, BL, n=102, 101, 98, 99, 94, 97 19 14 13 13 17 11
UP, 1+, BL, n=102, 101, 98, 99, 94, 97 6 6 7 7 6 11
UP, 2+, BL, n=102, 101, 98, 99, 94, 97 0 1 1 0 1 0
UP, 3+, BL, n=102, 101, 98, 99, 94, 97 1 2 0 1 0 0
UP, Neg, W8, n=63, 85, 84, 82, 82, 82 54 64 68 65 63 61
UP, Trace, W8, n=63, 85, 84, 82, 82, 82 6 14 8 12 17 15
UP, 1+, W8, n=63, 85, 84, 82, 82, 82 3 5 6 5 2 5
UP, 2+, W8,n=63, 85, 84, 82, 82, 82 0 2 1 0 0 0
UP, 3+, W8, n=63, 85, 84, 82, 82, 82 0 0 0 0 0 1
UP, 4+, W8, n=63, 85, 84, 82, 82, 82 0 0 1 0 0 0
UP, Neg, WD, n=9, 4, 1, 2, 3, 7 8 4 0 1 3 6
UP, Trace, WD, n=9, 4, 1, 2, 3, 7 0 0 1 1 0 0
UP, 1+, WD, n=9, 4, 1, 2, 3, 7 1 0 0 0 0 1
UWBC, Neg, BL, n=102, 101, 98, 99, 94, 97 86 87 82 81 74 88
UWBC, Trace, BL, n=102, 101, 98, 99, 94, 97 2 4 7 3 5 2
UWBC, 1+, BL, n=102, 101, 98, 99, 94. 97 6 5 4 7 8 3
UWBC, 2+, BL, n=102, 101, 98, 99, 94, 97 7 3 2 8 5 4
UWBC, 3+, BL, n=102, 101, 98, 99, 94, 97 1 2 3 0 2 0
UWBC, Neg, W8, n=63, 85, 84, 82, 82, 82 52 65 71 62 63 69
UWBC, Trace, W8, n=63, 85, 84, 82, 82, 82 3 5 4 7 7 3
UWBC, 1+, W8, n=63, 85, 84, 82, 82, 82 7 7 6 7 5 7
UWBC, 2+, W8, n=63, 85, 84, 82, 82, 82 1 7 3 5 7 3
UWBC, 3+, W8, n=63, 85, 84, 82, 82, 82 0 1 0 1 0 0
UWBC, Neg, WD, n=9, 4, 1, 2, 3, 7 9 4 0 1 3 7
UWBC, 2+, WD, n=9, 4, 1, 2, 3, 7 0 0 1 1 0 0
19.Secondary Outcome
Title Urine Specific Gravity at Baseline and Week 8/Early Withdrawal
Hide Description Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.
Time Frame Urine specific gravity at Baseline and Week 8/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 102 104 96 99 94 97
Mean (Standard Deviation)
Unit of Measure: ratio
BL, n=102, 101, 98, 99, 94, 97 1.0232  (0.00741) 1.0227  (0.00687) 1.0226  (0.00718) 1.0224  (0.00719) 1.0225  (0.00759) 1.0245  (0.00679)
W8, n=63, 85, 84, 82, 82, 82 1.0225  (0.00778) 1.0227  (0.00714) 1.0227  (0.00655) 1.0223  (0.00766) 1.0210  (0.00884) 1.0255  (0.00726)
WD, n=9, 4, 1, 2, 3, 7 1.0206  (0.00532) 1.0228  (0.00772) 1.0380  (0) 1.0175  (0.01768) 1.0273  (0.00306) 1.0164  (0.00824)
20.Secondary Outcome
Title Urine pH at Baseline and Week 8/Early Withdrawal
Hide Description Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time Frame Baseline and Week 8/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 102 104 96 99 94 97
Mean (Standard Deviation)
Unit of Measure: scores on a scale
BL, n=102, 104, 96, 99, 94, 97 6.11  (0.507) 5.98  (0.367) 6.05  (0.455) 5.97  (0.383) 6.01  (0.370) 6.04  (0.393)
W8, n=62, 84, 82, 83, 82, 82 6.00  (0.458) 6.13  (0.518) 6.10  (0.451) 5.99  (0.397) 6.00  (0.437) 6.01  (0.368)
WD, n=9, 4, 1, 2, 3, 7 6.11  (0.601) 6.13  (0.250) 6.00  (0) 6.00  (0.000) 5.67  (0.289) 5.93  (0.345)
21.Secondary Outcome
Title 24-hour Urinary Cortisol Excretion at Baseline and Week 8
Hide Description A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 56 69 75 75 72 70
Median (Full Range)
Unit of Measure: Nanomole per 24 hours (nmol/24hr)
Baseline
68.45
(12.9 to 261.2)
56.80
(6.8 to 385.4)
65.90
(9.6 to 463.5)
64.50
(20.1 to 311.0)
73.40
(12.5 to 221.7)
75.69
(17.9 to 384.8)
Week 8
64.70
(7.6 to 200.0)
60.80
(13.9 to 262.1)
53.00
(9.2 to 371.5)
56.00
(5.4 to 340.0)
62.00
(7.7 to 294.3)
58.39
(8.0 to 338.5)
22.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8
Hide Description Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 107 105 101 103 99 100
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
SBP 0.8  (9.83) 0.3  (12.93) -0.2  (12.06) 0.9  (11.51) 0.9  (10.55) 1.1  (11.49)
DBP 2.1  (6.96) 0.6  (9.19) -0.3  (9.18) 0.0  (9.37) -0.2  (8.05) 1.0  (7.90)
23.Secondary Outcome
Title Change From Baseline in Heart Rate at Week 8
Hide Description Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description:
Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 107 105 101 103 99 100
Mean (Standard Deviation)
Unit of Measure: Beats per minute
0.8  (10.12) 0.5  (7.65) -0.4  (8.90) 1.5  (10.92) 0.5  (8.55) -1.7  (9.68)
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
 
Arm/Group Title Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Hide Arm/Group Description Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study. Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
All-Cause Mortality
Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/105 (0.00%)   0/101 (0.00%)   1/103 (0.97%)   1/99 (1.01%)   0/100 (0.00%) 
Cardiac disorders             
Myocardial infarction † 1  0/107 (0.00%)  0/105 (0.00%)  0/101 (0.00%)  1/103 (0.97%)  0/99 (0.00%)  0/100 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Asthma † 1  0/107 (0.00%)  0/105 (0.00%)  0/101 (0.00%)  0/103 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo GW685698X 100 µg OD GW685698X 200 µg OD GW685698X 300 µg OD GW685698X 400 µg OD FP 250 µg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/107 (15.89%)   29/105 (27.62%)   18/101 (17.82%)   22/103 (21.36%)   20/99 (20.20%)   32/100 (32.00%) 
Gastrointestinal disorders             
Diarrhoea † 1  0/107 (0.00%)  4/105 (3.81%)  1/101 (0.99%)  1/103 (0.97%)  1/99 (1.01%)  1/100 (1.00%) 
Abdominal pain upper † 1  0/107 (0.00%)  2/105 (1.90%)  1/101 (0.99%)  1/103 (0.97%)  3/99 (3.03%)  0/100 (0.00%) 
Toothache † 1  0/107 (0.00%)  1/105 (0.95%)  1/101 (0.99%)  0/103 (0.00%)  0/99 (0.00%)  3/100 (3.00%) 
Infections and infestations             
Nasopharyngitis † 1  8/107 (7.48%)  9/105 (8.57%)  5/101 (4.95%)  7/103 (6.80%)  4/99 (4.04%)  7/100 (7.00%) 
Upper respiratory tract infection † 1  3/107 (2.80%)  2/105 (1.90%)  3/101 (2.97%)  1/103 (0.97%)  0/99 (0.00%)  6/100 (6.00%) 
Oral candidiasis † 1  0/107 (0.00%)  3/105 (2.86%)  1/101 (0.99%)  3/103 (2.91%)  3/99 (3.03%)  3/100 (3.00%) 
Sinusitis † 1  1/107 (0.93%)  2/105 (1.90%)  0/101 (0.00%)  0/103 (0.00%)  1/99 (1.01%)  3/100 (3.00%) 
Musculoskeletal and connective tissue disorders             
Back pain † 1  0/107 (0.00%)  1/105 (0.95%)  1/101 (0.99%)  3/103 (2.91%)  3/99 (3.03%)  2/100 (2.00%) 
Nervous system disorders             
Headache † 1  6/107 (5.61%)  9/105 (8.57%)  8/101 (7.92%)  8/103 (7.77%)  9/99 (9.09%)  8/100 (8.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough † 1  1/107 (0.93%)  2/105 (1.90%)  0/101 (0.00%)  2/103 (1.94%)  4/99 (4.04%)  2/100 (2.00%) 
Dysphonia † 1  1/107 (0.93%)  1/105 (0.95%)  0/101 (0.00%)  2/103 (1.94%)  2/99 (2.02%)  4/100 (4.00%) 
Oropharyngeal pain † 1  0/107 (0.00%)  2/105 (1.90%)  1/101 (0.99%)  1/103 (0.97%)  3/99 (3.03%)  3/100 (3.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00603278    
Other Study ID Numbers: FFA109685
First Submitted: December 27, 2007
First Posted: January 29, 2008
Results First Submitted: June 6, 2013
Results First Posted: August 12, 2013
Last Update Posted: December 28, 2016