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

NCT06018441 | Completed

• 2 other identifiers: OBS17526U1111-1279-3274
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

Study Arms (1)

Severe asthma

Participants with severe asthma starting treatment with dupilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with severe asthma

You may qualify if:

• Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site

France, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: October 3, 2023
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)