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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00512863 |
To evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of refractory asthma.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Humira (adalimumab) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel, Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma |
Estimated Enrollment: | 272 |
Study Start Date: | August 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | M05-757 |
Study First Received: | August 6, 2007 |
Last Updated: | November 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00512863 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Adalimumab Respiratory Hypersensitivity |
Anti-Inflammatory Agents Immune System Diseases Bronchial Diseases |
Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |