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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humira (adalimumab) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with at least one asthma exacerbation from Baseline to the end of the double-blind period | Week 16 | |
| Changes from Baseline in post-bronchodilator FEV1 | Time points other thanWeek 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Paperiello | Abbott | Study Director |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Change from Baseline in pre-bronchodilator FEV1 |
| Change from Baseline (pre-bronchodilator) in FEV1 | 30 minutes postbronchodilator |
| Change from Baseline in percent predicted FEV1 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |