drugset / Trial / NCT04763447

Short Treatment with Omalizumab for Severe Asthma

NCT04763447

Phase 4 Recruiting 234 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-05-20
Primary completion
2027-05-20
Completion
2027-05-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Omalizumab Monoclonal antibody Subcutaneous

Indications