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 Overview
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Brief Summary
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Primary Objective: - To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks compared to baseline. Secondary Objectives: To describe dupilumab HRQoL effectiveness at 12 and 24 weeks compared to baseline. To assess the safety during the year of treatment in a real-world setting.

Official Title
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National, Multicenter, Non-interventional, Prospective Study to Explore the Quality of Life of Patients With Severe Asthma Starting Treatment With Dupilumab (Dupixent®) in a Real-world Setting

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be at least 18 years of age inclusive, at the time of signing the informed consent. 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. 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. 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: Participant below 18 years of age. - Participant participating in a clinical trial at the time of enrolment. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe asthma<br>Participants with severe asthma starting treatment with dupilumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ) | 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. | Baseline (Day 0), Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ) | 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. | Baseline (Day 0), Week 12 and Week 24 | 
| 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 |