Asthma Clinical Trial
Official title:
Double Blind Study to Determine Effect of Omalizumab Treatment in Patients With the Co-Morbid Conditions of Aspirin Exacerbated Respiratory Disease(AERD) and Allergic Asthma and Rhinitis.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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