Shortening Omalizumab Treatment for Severe Asthma

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

This study is testing if people with well-controlled severe allergic asthma can stop taking the medication Omalizumab after a long time and still keep their asthma under control.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 234 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Drugs / interventions: mepolizumab, benralizumab, dupilumab, reslizumab, omalizumab
• Locations: 1 site (Paris, Île-de-France Region)
• Trial ID: NCT04763447 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of discontinuing Omalizumab (OMA) treatment in patients with well-controlled severe allergic asthma after at least 33 months of therapy. The research aims to determine if patients can maintain acceptable asthma control after stopping OMA, which is known to reduce severe exacerbations and improve asthma management. By assessing asthma control post-discontinuation, the study seeks to provide insights into the optimal duration of OMA therapy and its impact on patient quality of life and healthcare costs.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who have been treated with OMA for at least 33 months and have well-controlled asthma.

Not a fit: Patients who are not well-controlled on OMA or those who have experienced significant side effects or other contraindications to stopping treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to reduced treatment costs and fewer injections for patients with severe asthma while maintaining effective disease control.

How similar studies have performed: Previous studies have shown that some patients can maintain asthma control after discontinuing OMA, suggesting that this approach may be viable.

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 is considered poor or questionable by the investigator
* Patient participating in another intervention research
* Pregnant or lactating patient
* Patient refusing to sign consent

Where this trial is running

Paris, Île-de-France Region

• Hôpital Bichat-Claude Bernard — Paris, Île-de-France Region, France (RECRUITING)

Study contacts

• Principal investigator: Camille TAILLE, Professor — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Camille TAILLE, Professor

Conditions: Asthma, severe asthma, omalizumab, allergy, biologic