RecruitingPhase 4NCT04763447

Short Treatment with Omalizumab for Severe Asthma

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

234 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

Asthma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with severe allergic asthma who have been well-controlled on omalizumab (Xolair) for nearly 3 years can safely stop the medication without their asthma getting worse. **You may be eligible if...** - You are an adult (18 years or older) - You have been treated with omalizumab (prescribed by a lung specialist) for at least 33 months for severe allergic asthma - Your asthma has been well-controlled on this treatment (asthma control test score of 18 or higher) - You have had no more than one asthma attack in the past year **You may NOT be eligible if...** - Your asthma has not been well-controlled - You have been on omalizumab for less than 33 months - You have had more than one significant asthma attack in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAttempt 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

DRUGContinuation 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

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NCT04763447

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