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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00495612 |
This is a three-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction induced by environmental cat dander exposure in patients 18-65 years old with stable, moderate asthma and a history of cat dander-induced asthma symptoms. A total of approximately 82 patients will be randomized into this study.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: omalizumab Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-Induced Asthma |
Estimated Enrollment: | 82 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: omalizumab
Subcutaneous injection
|
2: Placebo Comparator |
Drug: placebo
Subcutaneous injection
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Allergy Research Foundation | |
Los Angeles, California, United States, 90025 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
Canada, Ontario | |
Cetero-Allied Research Intl | |
Mississauga, Ontario, Canada, L4W 1N2 |
Study Director: | James Fish, M.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | Q4229n |
Study First Received: | June 29, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00495612 |
Health Authority: | United States: Institutional Review Board |
Xolair Allergic Asthma Cat Allergy |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Omalizumab Respiratory Hypersensitivity |
Respiratory System Agents Immune System Diseases Bronchial Diseases Therapeutic Uses |
Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions |