Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma
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|ClinicalTrials.gov Identifier: NCT00286416|
Recruitment Status : Unknown
Verified January 2006 by Scripps Health.
Recruitment status was: Recruiting
First Posted : February 3, 2006
Last Update Posted : November 7, 2006
|Condition or disease||Intervention/treatment||Phase|
|Asthma Allergic Rhinitis||Drug: omalizumab (Xolair)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||January 2006|
|Study Completion Date :||July 2008|
- Respiratory Index scores
- Nasal Flow rates
- Nasal smell scores
- Quality of Life Scores for rhinitis and asthma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286416
|United States, California|
|Scripps Clinic at Torrey Pines||Recruiting|
|La Jolla, California, United States, 92037|
|Contact: Christine Decker-Hughes, RN 858-554-8653 firstname.lastname@example.org|
|Contact: Donald D Stevenson, MD 858-554-8614 email@example.com|
|Principal Investigator: Donald D Stevenson, MD|
|Study Chair:||Gary Willaims, MD, PhD||Vice Chairman of Academic Affairs|