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| Sponsored by: |
Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00046748 |
Purpose
The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Omalizumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Ph III, 28-Wk, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Efficacy, Safety, Tolerability of SC Omalizumab in Adults and Adolescents w/ Severe Persist. Allergic Asthma & Are Inadequately Controlled Despite GINA (2002) Step 4 Tx |
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2001 |
| Estimated Study Completion Date: | January 2004 |
Eligibility| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
or:
been admitted to hospital (including intensive care unit) or received emergency room (including urgent care centers) treatment in the past 12 months for an asthma exacerbation, which in accordance with the GINA guidelines met all of the following criteria for a severe exacerbation:
Contacts and Locations
More Information
| Study ID Numbers: | CIGE025A2306 |
| Study First Received: | October 2, 2002 |
| Last Updated: | August 14, 2006 |
| ClinicalTrials.gov Identifier: | NCT00046748 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Lung Diseases Hypersensitivity, Immediate |
Anti-Asthmatic Agents Asthma Anti-Allergic Agents Omalizumab Respiratory Hypersensitivity |
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Respiratory System Agents Bronchial Diseases Immune System Diseases Anti-Asthmatic Agents Asthma Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Lung Diseases Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity Omalizumab |