Clinical trial NCT06018441: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with severe asthma

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.


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.

Primary outcomes:
measure: Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline (Day 0), Week 52
Secondary outcomes:
measure: Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline (Day 0), Week 12 and Week 24
measure: Number of participants with adverse events (AEs)
timeFrame: Day 0 to Week 52
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Day 0 to Week 52
measure: Number of participants with adverse events of special interest
timeFrame: Day 0 to Week 52
measure: Number of participants with medication errors
timeFrame: Day 0 to Week 52
Other outcomes:
Locations:
city: France
country: France
facility: Investigational Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: