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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
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

CompletedN/A

Sponsor: Sanofi

Conditions: Asthma

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (1)
  • France, France