Active — Not RecruitingNot Applicable

Use of Dupilumab in Asthma in Real-world Setting

France35,000 participantsStarted 2025-01-02

Plain-language summary

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

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is listed as 'active, not recruiting' — does that mean there's any chance of joining it now, or is it completely closed to new participants?
2Since this study is focused on collecting real-world data about patient characteristics rather than testing a new treatment, what would my role actually look like — would I be receiving dupilumab as part of the trial, or just being observed and tracked?
3Dupilumab is already approved for asthma in some patients — based on my specific type of asthma, do you think I might be a candidate for dupilumab outside of a trial through standard care?
4Because this study is phase 'NA' and observational in nature, what does that tell us about how much is already known about dupilumab's safety and effectiveness for people with my asthma profile?
5Are there other active trials or standard treatment paths for my acute asthma that you think would be a better fit for me right now, given that this particular study isn't enrolling new patients?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient's characteristics

Timeframe: At index date, i.e. at the date of the 1st reimbursement of Dupilumab over the inclusion period (betw Nov 10, 2020 and Dec 31, 2023)

Trial details

NCT IDNCT07637292

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-01

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