Clinical Trial

Short Treatment with Omalizumab for Severe Asthma

Study acronym: SHORTEN
Recruiting Phase 4
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-02-18; most recent amendment 2024-11-06.
Status change: Not Yet Recruiting → Recruiting 2022-02-09
Trial Details
NCT Number NCT04763447
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Asthma
Enrollment 234 participants
Start Date 2021-05-20
Primary Completion 2027-05-20 (estimated)
Study Completion 2027-05-20 (estimated)
Updated on ClinicalTrials.gov 2024-11-07