NCT06018441Completed
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
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
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 112 (actual)
- First submitted
- 24 Aug 2023
- Start date
- 3 Oct 2023
- Primary completion date
- 10 Oct 2025
- Lead sponsor
- Sanofi
- Diseases
- Asthma
- NCT number
- NCT06018441
What you commit to
- Study type: Observational
- Participants enrolled: 112
- From 3 Oct 2023 to the primary completion date, 10 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Participant below 18 years of age. - Participant participating in a clinical trial at the time of enrolment.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational Site Coordinator of this site? Confirm its status | France | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.