Impact of Omalizumab Withdrawal After a 3 Year Duration Treatment in Well Controlled Severe Allergic Asthma : a Multicentric Randomized Controlled Trial

APHP180614

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 33 to 63 months of treatment when asthma is well controlled.

2021-05-20

2025-05-20

2025-05-20

Recruiting

Early phase I

234

Inclusion Criteria: * Adult patient \>18 years old * Treated with OMA, prescribed by a pulmonologist , for 33 to 63 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 is considered poor or questionable by the investigator * Patient participating in another intervention research * Pregnant or lactating patient * Patient refusing to sign consent

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 234, 'type': 'ESTIMATED'}}

2024-01-18