Status:
COMPLETED
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
Lead Sponsor:
Sanofi
Conditions:
Asthma
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 3 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 10 2025
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06018441
Start Date
October 3 2023
End Date
October 10 2025
Last Update
December 9 2025
Active Locations (1)
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1
Investigational Site
France, France