Asthma
Conditions
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.
Interventions
None listed
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ) | Baseline (Day 0), Week 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | — |
Countries
France
Outcome results
None listed