Status:
RECRUITING
Short Treatment with Omalizumab for Severe Asthma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The optimal duration of the treatment by OMA remains unclear when asthma is well controlled. Data suggest that a large part of patients with well controlled asthma can discontinue OMA therapy without ...
Detailed Description
Omalizumab (OMA) is a monoclonal anti IgE antibody, developed for severe uncontrolled allergic asthma. Efficacy of OMA in this indication is well documented in randomized trials as well as in real lif...
Eligibility Criteria
Inclusion
- Adult patient \>18 years old
- Treated with OMA, prescribed by a pulmonologist , for at least 33 months for severe allergic asthma
- Well controlled with the treatment (ACT score ⩾ 18) and having experienced no more than one exacerbation in the year preceding inclusion. An exacerbation is defined as an oral or injectable steroid course for at least 2 days and/or a minimum doubling of the usual steroid dose for at least 2 days for steroid dependent patients
Exclusion
- Patient refusing to stop OMA treatment, whatever the reason
- Patient with other reason other than good asthma control to stop OMA, such as a side effect, planned or ongoing pregnancy, or planned switch to another step 5 asthma treatment (mepolizumab, benralizumab, dupilumab, reslizumab, daily oral steroids, bronchial thermoplasty, …)
- Patient not covered by Health Insurance
- Patient under curatorship, guardianship or safeguarding of justice
- Patient whose adherence to asthma treatments is considered poor or questionable by the investigator
- Patient participating in another intervention research
- Pregnant or lactating patient
- Patient refusing to sign consent
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2027
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04763447
Start Date
May 20 2021
End Date
May 20 2027
Last Update
November 7 2024
Active Locations (1)
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1
Hôpital Bichat-Claude Bernard
Paris, Île-de-France Region, France, 75018