This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05599191
Recruitment Status : Recruiting
First Posted : October 31, 2022
Last Update Posted : February 15, 2024
Sponsor:
Information provided by (Responsible Party):
Bellus Health Inc. - a GSK company

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Condition or disease Intervention/treatment Phase
Refractory Chronic Cough Drug: BLU-5937 Drug: Placebo Phase 3

Detailed Description:
The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 12 weeks.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough
Actual Study Start Date : October 25, 2022
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: BLU-5937 25 mg
BLU-5937 oral dose 25 mg twice a day.
 Drug: BLU-5937
Oral administration of BLU-5937 Tablets
Experimental: BLU-5937 50 mg
BLU-5937 oral dose 50 mg twice a day.
 Drug: BLU-5937
Oral administration of BLU-5937 Tablets
Placebo Comparator: Placebo
Matching Placebo for BLU-5937 oral dose twice a day.
 Drug: Placebo
Oral administration of matching placebo for BLU-5937 Tablets


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 24-Hour Cough Frequency [ Time Frame: Week 12 ]
    Assessed using an ambulatory cough monitor


Secondary Outcome Measures :
  1. Change from Baseline in Cough Severity Visual Analogue Scale at Week 12 [ Time Frame: Baseline, Week 12 ]
    Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.

  2. Percentage of Participants With ≥ 30mm Reduction, ≥ 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.

  3. Percentage of Participants With ≥30%, ≥50%, and ≥70% Reduction From Baseline in 24-Hour Cough Frequency at Week 12 [ Time Frame: Baseline, Week 12 ]
    Assessed using an ambulatory cough monitor

  4. Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.

  5. Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of giving signed informed consent
  • Refractory chronic cough (including unexplained chronic cough) for at least one year
  • Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose

Exclusion Criteria:

  • Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
  • Respiratory tract infection within 4 weeks before screening
  • Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening
  • History of malignancy in the last 5 years
  • History of alcohol or drug abuse within the last 3 years
  • Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
  • Previous participation in a BLU-5937 trial
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05599191


Contacts
Layout table for location contacts
Contact: US GSK Clinical Trials call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
Show Show 183 study locations
Sponsors and Collaborators
Bellus Health Inc. - a GSK company
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bellus Health Inc. - a GSK company
ClinicalTrials.gov Identifier: NCT05599191    
Other Study ID Numbers: 221850
BUS-P3-01 ( Other Identifier: Bellus Health Inc )
First Posted: October 31, 2022    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cough
Chronic Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory