When to stop dupilumab in severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, non-inferiority trial asks if stopping dupilumab after at least 3 years of treatment leads to more frequent or severe worsening of asthma than continuing the medication. Adults with well-controlled severe asthma on dupilumab for at least 3 years, and with minimal exacerbations, are assigned to stopping or continuing the drug and followed for 24 months. Participants will have in-person visits at baseline, 6, 12, and 24 months, plus a phone check at 18 months to monitor exacerbations, treatments, and safety. The study aims to inform whether long-term dupilumab can be safely withdrawn in a real-world setting. Lead site is University Hospital, Toulouse, with additional sites in Amiens and Angers, France.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients ≥ 18 years old
* Treated with dupilumab for at least 36 months for severe asthma
* Well controlled asthma defined by an Asthma Control Questionnaire score ≥ 18 and 0 or 1 exacerbation within the year prior to the inclusion visit

Exclusion Criteria:

* Patients who refuse to discontinue dupilumab, for any reason
* Patients with Forced expiratory volume in one second ≤ 30% of predicted values
* Patients treated by an oral corticosteroid dose ≥ 10 mg/day (in prednisone equivalent)
* Patients who have to discontinue dupilumab for a reason other than controlled asthma, such as an adverse drug reaction, a planned or current pregnancy, or a planned switch to another biologic indicated in severe asthma
* Patients who have to continue dupilumab for the treatment of comorbidities apart from nasal polyposis
* Active smoking
* Pregnancy or breastfeeding

Where it's running

• CHU de Toulouse
  Toulouse, CHU de Toulouse, France Recruiting
• CHU de Besançon
  Besançon, France, France Recruiting
• CHU de Dijon
  Dijon, France, France Recruiting
• CHU Grenoble-Alpes
  La Tronche, France, France Recruiting
• Hôpital Kremlin Bicêtre
  Le Kremlin-Bicêtre, France, France Recruiting
• Institut Coeur Poumon, CHU de Lille
  Lille, France, France Recruiting

Study contacts

• Principal investigator: Laurent GUILLEMINAULT, MD, PhD — University Hospital, Toulouse
• Study coordinator: Laurent GUILLEMINAULT, Md, PhD
• Email: guilleminault.l@chu-toulouse.fr
• Phone: 0567771850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.