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

Who is this study for? Patients with well controlled severe allergic asthma
What treatments are being studied? Omalizumab
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Bichat-Claude Bernard
RECRUITING
Paris
Contact Information
Primary
Camille TAILLE, Professor
camille.taille@aphp.fr
01 40 25 68 63
Time Frame
Start Date: 2021-05-20
Estimated Completion Date: 2027-05-20
Participants
Target number of participants: 234
Treatments
Experimental: OMA withdrawal attempt
Patients will be told to stop abruptly (no progressive decrease of the dose) their Omalizumab treatment and they will not be prescribed new OMA
Active_comparator: OMA continuation
Patients will be prescribed the same dosage of Omalizumab than they received before randomization
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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