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Recruiting Phase 4 NCT04763447

Short Treatment with Omalizumab for Severe Asthma

Trial Parameters

Condition Asthma
Sponsor Assistance Publique - Hôpitaux de Paris
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 234
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-05-20
Completion 2027-05-20
Interventions
Attempt to withdrawal OMA treatmentContinuation of OMA treatment

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 any asthma control deterioration or with an acceptable decrease in asthma control, therefore French experts propose that omalizumab can be given for "3 to 5 yrs if asthma remains well controlled". The costs related to OMA are high and frequent injections represent severe constraints for patients. For all these reasons, evaluating whether shortening duration of OMA therapy is feasible while maintaining acceptable asthma control is a critical point. Therefore, the aim of this study is to evaluate asthma control after OMA discontinuation after at least 33 months of treatment when asthma is well controlled.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

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