History of Changes for Study: NCT04184284

Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions (imPROve)

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Study Record Versions

Version	Submitted Date	Changes
1	November 29, 2019	None (earliest Version on record)
2	December 18, 2019	Recruitment Status, Study Status and Contacts/Locations
3	January 21, 2020	Contacts/Locations and Study Status
4	February 20, 2020	Contacts/Locations and Study Status
5	March 18, 2020	Contacts/Locations and Study Status
6	April 16, 2020	Contacts/Locations and Study Status
7	May 15, 2020	Contacts/Locations and Study Status
8	June 5, 2020	Contacts/Locations and Study Status
9	July 17, 2020	Contacts/Locations and Study Status
10	August 25, 2020	Study Status and Study Design
11	September 30, 2020	Study Status and Contacts/Locations
12	October 30, 2020	Contacts/Locations and Study Status
13	December 8, 2020	Study Status and Contacts/Locations
14	December 18, 2020	Outcome Measures and Study Status
15	January 28, 2021	Outcome Measures, Study Status, Study Design, Eligibility and Study Identification
16	February 16, 2021	Study Status
17	March 30, 2021	Contacts/Locations and Study Status
18	April 23, 2021	Study Status
19	May 26, 2021	Study Status
20	June 28, 2021	Study Status
21	September 20, 2021	Study Status and Study Design
22	October 4, 2021	Study Status
23	November 4, 2021	Study Status
24	December 6, 2021	Study Status
25	January 17, 2022	Recruitment Status, Study Status, Contacts/Locations and Study Design
26	February 15, 2022	Study Status
27	May 19, 2022	Study Status
28	August 12, 2022	Study Status and Study Design
29	November 3, 2022	Study Status
30	February 6, 2023	Study Status
31	May 25, 2023	Eligibility and Study Status
32	August 18, 2023	Study Status
33	November 13, 2023	Study Status
34	January 25, 2024	Recruitment Status and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	D3250R00053
Brief Title:	Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions (imPROve)
Official Title:	imPROve-asthma - A Prospective, 12-month, Observational Study to Investigate the Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Biologic Therapy Under Real-life Conditions in Germany
Secondary IDs:

Study Status


Record Verification:	November 2019
Overall Status:	Not yet recruiting
Study Start:	December 15, 2019
Primary Completion:	March 31, 2022 [Anticipated]
Study Completion:	March 31, 2022 [Anticipated]

First Submitted:	October 13, 2019
First Submitted that Met QC Criteria:	November 29, 2019
First Posted:	December 3, 2019 [Actual]

Last Update Submitted that Met QC Criteria:	November 29, 2019
Last Update Posted:	December 3, 2019 [Actual]

Sponsor/Collaborators


Sponsor:	AstraZeneca
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description

Brief Summary:

The main aim of this study is to investigate the change in asthma control after 6 months of therapy in patients treated with benralizumab biologic therapy for severe eosinophilic asthma under real-life conditions in a pulmonary care setting in Germany. The study also aims to investigate Quality-of-Life (QoL), the early treatment response, treatment effectiveness and the change in asthma control over time, following benralizumab therapy. This study will also describe the physician-chosen reasons for starting beralizumab therapy or switching to benralizumab therapy.

Detailed Description:

Conditions


Conditions:	Asthma
Keywords:	benralizumab

Study Design


Study Type:	Observational [Patient Registry]
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	500 [Anticipated]
Number of Groups/Cohorts	2
Target Follow-Up Duration:	12 Months

Groups and Interventions

Groups/Cohorts	Interventions
Primary Study Cohort - Anti-IL5/IL5R naïve patients Severe eosinophilic asthma patients who have never received anti-Interleukin-5 / anti-Interleukin-5-receptor (anti-IL-5/anti-IL-5R) biologic treatment for severe eosinophilic asthma, for whom the investigator had decided to initiate benralizumab biologic treatment.
Secondary Study Cohort - Biologic experienced patients Patients that previously received a biologic treatment for severe asthma (at least one dose).

Outcome Measures


Primary Outcome Measures:
1.	The change in asthma control after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment [ Time Frame: Baseline and 6 months after baseline ] Change from baseline in (Asthma Control Test - questionnaire) ACT score after 6 months treatment in anti-IL5/IL5R naïve patients. ACT is a simple, validated, 5-item tool giving a total score from 5 (worst control) to 25 (best control). Scores of 20 to 25 denote well-controlled asthma, scores ≤19 identifies patients with poorly controlled asthma. The minimum clinically important difference (MCID) is reported to be 3 points.
Secondary Outcome Measures:
1.	The investigator reported treatment effectiveness after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment [ Time Frame: 6 months after first treatment ] Investigator-reported treatment effectiveness using GETE (Global Evaluation of Treatment Effectiveness) after 6 months of treatment. GETE grades overall treatment effectiveness using the following criteria: excellent (complete control of asthma); good (marked improvement of asthma); moderate (discernible, but limited improvement in asthma); poor (no appreciable change in asthma); or worsening (of asthma).
2.	The change in health-related quality of life (HRQL) in anti-IL5/IL5R naïve patients initiated with benralizumab treatment [ Time Frame: Baseline and 6 months after first treatment ] Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score and domain scores (symptoms, activity and impact score) after 6 months treatment in anti-IL5/IL5R naïve patients. SGRQ is a validated, 50-item questionnaire, giving scores ranging from 0 (best health status) to 100 (worst health status). The SGRQ yields a total score and 3 domain scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. A difference of four units in the SGRQ total score is considered the MCID.
3.	The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, ACQ-6 [ Time Frame: Baseline and day 7 after first treatment ] Change from baseline in ACQ-6 (Asthma-Control-Questionnaire-6) score after 7 days of treatment in anti-IL5/IL5R naïve patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5.
4.	The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-1 [ Time Frame: Baseline and day 7 after first treatment ] Change from baseline in patient satisfaction, measured on Visual Analogue Scale (VAS), after 7 days of treatment in anti-IL5/IL5R naïve patients. VAS Scores ranged from "extremly satisfied" (0 mm) to "not at all satisfied" (100 mm).
5.	The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-2 [ Time Frame: Baseline and day 7 after first treatment ] Change from baseline in patient symptoms, measured on Visual Analogue Scale (VAS), after 7 days of treatment in anti-IL5/IL5R naïve patients. VAS Scores ranged from "not at all bothersome" (0 mm) to "extremly bothersome" (100 mm).
6.	The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, ACQ-6 [ Time Frame: Baseline and day 14 after first treatment ] Change from baseline in ACQ-6 (Asthma-Control-Questionnaire-6) score after 14 days of treatment in anti-IL5/IL5R naïve patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5.
7.	The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, VAS-1 [ Time Frame: Baseline and day 14 after first treatment ] Change from baseline in patient satisfaction, measured on Visual Analogue Scale (VAS), after 14 days of treatment in anti-IL5/IL5R naïve patients. VAS Scores ranged from "extremly satisfied" (0 mm) to "not at all satisfied" (100 mm).
8.	The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, VAS-2 [ Time Frame: Baseline and day 14 after first treatment ] Change from baseline in patient symptoms, measured on Visual Analogue Scale (VAS), after 14 days of treatment in anti-IL5/IL5R naïve patients. VAS Scores ranged from "not at all bothersome" (0 mm) to "extremly bothersome" (100 mm).
9.	The change of asthma control over time and the maintained response after initiation of benralizumab treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment using ACT [ Time Frame: Date of enrollment until end of follow-up (approx. 12 months after enrollment) ] Change from baseline in asthma control at each visit during the study period, using ACT in anti-IL5/IL5R naïve patients. ACT is a simple, validated, 5- item tool giving a total score from 5 (worst control) to 25 (best control). Scores of 20 to 25 denote well-controlled asthma, scores ≤19 identifies patients with poorly controlled asthma. The minimum clinically important difference (MCID) is reported to be 3 points.
10.	The change of asthma control over time and the maintained response after initiation of benralizumab treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment using ACQ-6 [ Time Frame: Date of enrollment until end of follow-up (approx. 12 months after enrollment) ] Change from baseline in asthma control at each visit during the study period, using ACQ-6 in anti-IL5/IL5R naïve patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5.
11.	The reasons for biologic treatment change [ Time Frame: Date of enrollment until end of follow-up (approx. 12 months after enrollment) ] Investigator-chosen reasons for Initiation of benralizumab / switching to benralizumab (treatment change from one biologic to another, regardless of the time since the last dose of the previous biologic) at enrolment discontinuation of benralizumab during the treatment period
Other Outcome Measures:
1.	The change of physical activity over time in anti-IL5/IL5R naïve patients [ Time Frame: Baseline until end of follow-up (approx. 12 months after enrollment) ] Change from baseline in steps per day over 12 months of treatment in anti-IL5/IL5R naïve patients.
2.	The change in asthma control after 6 and 12 months of treatment in biologic experienced patients [ Time Frame: Baseline, 6 and 12 months after first treatment ] Change from baseline in (Asthma Control Test - questionnaire) ACT score at the end of 6 and 12 months of benralizumab treatment in biologic experienced patients. ACT is a simple, validated, 5-item tool giving a total score from 5 (worst control) to 25 (best control). Scores of 20 to 25 denote well-controlled asthma, scores ≤19 identifies patients with poorly controlled asthma. The minimum clinically important difference (MCID) is reported to be 3 points.
3.	The change in asthma control and the maintained response after initiation of benralizumab treatment in biologic experienced patients using ACQ-6 [ Time Frame: Baseline, 6 and 12 months after first treatment ] Change from baseline in ACQ-6 (Asthma-Control-Questionnaire-6) score at the end of 6 and 12 months of benralizumab treatment in biologic experienced patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5.
4.	The change in HRQL after 6 and 12 months of treatment in biologic experienced patients [ Time Frame: Baseline, 6 and 12 months after first treatment ] Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score and domain scores (symptoms, activity and impact score) after 6 and 12 months treatment in biologic experienced patients. SGRQ is a validated, 50-item questionnaire, giving scores ranging from 0 (best health status) to 100 (worst health status). The SGRQ yields a total score and 3 domain scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. A difference of four units in the SGRQ total score is considered the MCID.
5.	The early treatment response in biologic experienced patients initiated with benralizumab treatment, ACQ-6 [ Time Frame: Baseline, day 7 and day 14 after first treatment ] Change from baseline in ACQ-6 (Asthma-Control-Questionnaire-6) score after 7 and 14 days of treatment in biologic experienced patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5.
6.	The early treatment response in biologic experienced patients initiated with benralizumab treatment, patient satisfaction, VAS-1 [ Time Frame: Baseline, day 7 and day 14 after first treatment ] Change from baseline in patient satisfaction, measured on Visual Analogue Scale (VAS), after 7 and 14 days of treatment in biologic experienced patients. VAS Scores ranged from "extremly satisfied" (0 mm) to "not at all satisfied" (100 mm).
7.	The early treatment response in biologic experienced patients initiated with benralizumab treatment, patient symptoms, VAS-2 [ Time Frame: Baseline, day 7 and day 14 after first treatment ] Change from baseline in patient symptoms, measured on Visual Analogue Scale (VAS), after 7 and 14 days of treatment in biologic experienced patients. VAS Scores ranged from "not at all bothersome" (0 mm) to "extremly bothersome" (100 mm).
8.	The investigator reported treatment effectiveness after 6 months of treatment in biologic experienced patients initiated with benralizumab treatment [ Time Frame: 6 months after first treatment ] Investigator-reported treatment effectiveness using GETE (Global Evaluation of Treatment Effectiveness) after 6 months of treatment. GETE grades overall treatment effectiveness using the following criteria: excellent (complete control of asthma); good (marked improvement of asthma); moderate (discernible, but limited improvement in asthma); poor (no appreciable change in asthma); or worsening (of asthma).

Eligibility


Study Population:	approximately 350 to 500 patients in 40 pulmonology sites (hospitals and outpatient practices) in Germany Primary study cohort: approximately 250 patients Secondary study cohort: approximately 100 to 250 patients
Sampling Method:	Probability Sample
Minimum Age:
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Male or female patients aged 18 years or older with confirmed diagnosis of severe asthma according to the ATS/ERS and local German guidelines Decision was made by the investigator (regardless of this NIS) to start treating the patient with benralizumab according to severe eosinophilic asthma indication (NB: can include patients that are switched from another EU approved biologic treatment if required for a medical reason). Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study. Exclusion Criteria: Concomitant treatment with any other biologic for any indication Patients already treated with benralizumab Clinically important pulmonary disease other than asthma including: chronic obstructive pulmonary disease (as main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis). An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results. Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Acceptable wash-out periods for other asthma biologics: ≥30 days from last dose of previous biologic Pregnancy or lactation period Participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 3 months

Contacts/Locations


Central Contact Person:	AstraZeneca Clinical Study Information Center Telephone: 1-877-240-9479 Email: information.center@astrazeneca.com
Locations:

IPDSharing


Plan to Share IPD:

References


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