Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Scripps Clinic
Updated on 7 November 2020
aspirin
asthma
rhinitis
allergic asthma
respiratory disorder
omalizumab

Summary

Double blind protocol treatment of 2/3 of the patients with omalizumab and 1/3 placebo administer for 4 months. Patients selected for the study must have both aspirin exacerbated respiratory disease and allergic asthma and rhinitis. They must also have completed aspirin desensitization and be taking aspirin on a daily basis for the treatment of AERD.

Description

60 patients with Aspirin Exacerbated respiratory Disease will be screened to determine if they also have allergic respiratory tract disease as a co-morbid complication. This will involve history, allergy skin tests and a serum IgE level. They must also have been desensitized to aspirin and be taking aspirin 325 or 650 mg morning and night. 40/60 patients will receive omalizumab injections every month for the next 4 months and the other 20 patients, via a random program, will receive placebo injections. Monthly visits with the nurse co-ordinator will involve the following assessments: daily symptom scores, daily use of medications (particularly prednisone and rescue albuterol inhalers), lung function tests, nasal breathing test, measurement of smell and quality of life scores pre and post study.

Details
Condition Asthma
Treatment omalizumab (Xolair)
Clinical Study IdentifierNCT00286416
SponsorScripps Clinic
Last Modified on7 November 2020

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