PROVERB: A Study to Evaluate the Quality of Life in Male and Female Adult Participants With Severe Asthma Treated With Dupilumab in a Real-world Setting
Study Details
Study Description
Brief Summary
Primary Objective:
- To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks compared to baseline.
Secondary Objectives:
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To describe dupilumab HRQoL effectiveness at 12 and 24 weeks compared to baseline.
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To assess the safety during the year of treatment in a real-world setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Severe asthma Participants with severe asthma starting treatment with dupilumab |
Outcome Measures
Primary Outcome Measures
- Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ) [Baseline (Day 0), Week 52]
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Secondary Outcome Measures
- Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ) [Baseline (Day 0), Week 12 and Week 24]
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
- Number of participants with adverse events (AEs) [Day 0 to Week 52]
- Number of participants with serious adverse events (SAEs) [Day 0 to Week 52]
- Number of participants with adverse events of special interest [Day 0 to Week 52]
- Number of participants with medication errors [Day 0 to Week 52]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
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Participant for whom decision of initiation and prescription of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was made by the investigator within four weeks before the inclusion in the study. Oral CorticoSteroid (OCS) or non-OCS-dependent patient could be included.
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Participant for whom St. George's Respiratory Questionnaire (SGRQ) score is available within the last 4 weeks prior to dupilumab initiation. SGRQ score could be collected at baseline visit for participants who have not yet started dupilumab.
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Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
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Participant below 18 years of age. - Participant participating in a clinical trial at the time of enrolment.
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Participant under guardianship, trusteeship or under judicial protection. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OBS17526
- U1111-1279-3274