Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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.|
- Respiratory Index scores
- Nasal Flow rates
- Nasal smell scores
- Quality of Life Scores for rhinitis and asthma
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||July 2008|
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.
|United States, California|
|Scripps Clinic at Torrey Pines||Recruiting|
|La Jolla, California, United States, 92037|
|Contact: Christine Decker-Hughes, RN 858-554-8653 email@example.com|
|Contact: Donald D Stevenson, MD 858-554-8614 firstname.lastname@example.org|
|Principal Investigator: Donald D Stevenson, MD|
|Study Chair:||Gary Willaims, MD, PhD||Vice Chairman of Academic Affairs|