NCT07637292Active, not recruiting
Use of Dupilumab in Asthma in Real-world Setting
Use of Dupilumab in Asthma in Real-world Setting: Analysis of the SNDS Database
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
The main objective of asthma pharmacological management in adults and teenagers is to maintain long-term control of the disease, including symptom relief, the prevention of exacerbations, the improvement of pulmonary function, the reduction of limitations in daily life and side effects of pharmacological treatments. Dupilumab is a recombinant human monoclonal antibody that inhibits signalling of both IL-4 and IL-13, two Type 2 cytokines involved in inflammatory pathway. Dupixent obtained a European Marketing Authorization in September 2017 and was reimbursed in France from March 5, 2019 in adults with moderate-to-severe atopic dermatitis. On November 10, 2020, the reimbursement of Dupixent was extended to adults and adolescents aged 12 and over as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils (≥ 0.150 g/L) and/or raised fraction of exhaled nitric oxide (FeNO ≥ 20 ppb), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Lastly, on July 22, 2021, Dupixent was also reimbursed in patients with severe nasal polyposis. Primary objective: To describe the characteristics of patients using dupilumab for severe asthma in a real-world setting. Secondary objectives: * To describe the Health Care Resource Use (HCRU) and associated costs of severe asthmatic patients using dupilumab. * To describe the use of corticosteroids (oral and inhaled) before and after dupilumab initiation. * To study persistence with dupilumab in real-world
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 35000 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- 2 Jan 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Asthma
- NCT number
- NCT07637292
What you commit to
- Study type: Observational
- Planned participants: 35000
- From 2 Jan 2025 to the primary completion date, 1 Sept 2026
- 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.
Other
- \-
Who the study is looking for
- At least one reimbursement of dupilumab during the inclusion period from November 10, 2020 to December 31, 2023
- At least one of the following asthma markers:
- at least one reimbursement of inhaled corticosteroids (ICS and fixed-dose combination ICS/LABA inhalers) in a 3-month time-window before and after one of the reimbursement of dupilumab
- A Long-Term Disease (LTD) for asthma in the 12 months before dupilumab initiation or over follow-up.
- An hospital admission for asthma in the 12 months before dupilumab initiation or over follow-up.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.