NCT04763447 Short Treatment with Omalizumab for Severe Asthma
| NCT ID | NCT04763447 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2021-05-20 |
| Primary Completion | 2027-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 234 participants in total. It began in 2021-05-20 with a primary completion date of 2027-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Camille TAILLE, Professor
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04763447 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04763447 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04763447 currently recruiting?
Yes, NCT04763447 is actively recruiting participants. Contact the research team at camille.taille@aphp.fr for enrollment information.
Where is the NCT04763447 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04763447 clinical trial?
NCT04763447 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Camille TAILLE, Professor at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 234 participants.
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