Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04763447

Short Treatment with Omalizumab for Severe Asthma

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-11-07

234

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Short Treatment with Omalizumab for Severe Asthma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient >18 years old
  • Treated with Omalizumab prescribed by a pulmonologist for at least 33 months for severe allergic asthma
  • Well controlled asthma with treatment (ACT score 218) and no more than one exacerbation in the past year, defined by steroid use for at least 2 days
Not Eligible

You will not qualify if you...

  • Patient refusing to stop Omalizumab treatment
  • Stopping Omalizumab for reasons other than good asthma control, such as side effects, pregnancy, or switching to another advanced asthma treatment
  • Not covered by health insurance
  • Under curatorship, guardianship, or judicial protection
  • Poor or questionable adherence to asthma treatments
  • Participating in another intervention study
  • Pregnant or breastfeeding
  • Refusing to sign consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpital Bichat-Claude Bernard

Paris, Île-de-France Region, France, 75018

Actively Recruiting

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Research Team

C

Camille TAILLE, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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