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Short Treatment with Omalizumab for Severe Asthma
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Official title: Impact of Omalizumab Withdrawal After a 3 Year Duration Treatment in Well Controlled Severe Allergic Asthma : a Multicentric Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2021-05-20
Completion Date
2027-05-20
Last Updated
2024-11-07
Healthy Volunteers
No
Conditions
Interventions
Attempt to withdrawal OMA treatment
Patients will be told to stop abruptly (no progressive decrease of the dose) their Omalizumab treatment and they will not be prescribed new OMA. In case of loss of control, pulmonologist can adapt asthma treatment, as in usual care. In that case, OMA can be prescribed for a second line
Continuation of OMA treatment
Patients will be prescribed the same dosage of Omalizumab than they received before randomization, according to their weight and total circulating IgE levels. In case of safety concerns or loss of control, pulmonologist can modify the patient treatment regimen of OMA or other co-medications, as in usual care.
Locations (1)
Hôpital Bichat-Claude Bernard
Paris, Île-de-France Region, France