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

Active, not recruiting

• Conditions: Asthma

• Registration Number: NCT06018441
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-30
• Study Start: 2023-10-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-10-03
• Study Completion: 2025-10-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of participants with serious adverse events (SAEs)	Day 0 to Week 52
Number of participants with adverse events (AEs)	Day 0 to Week 52
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 medication errors	Day 0 to Week 52
Number of participants with adverse events of special interest	Day 0 to Week 52

Trial Locations

Locations (1)

Investigational Site; 🇫🇷 France, France