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This study is to designed to test the role of complement in the late asthmatic response to allergen challenge in mild asthma, as an indicator of the possible role of complement in the broader asthmatic population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eculizumab | Drug | eculizumab 600 mg or matching placebo iv infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Allergen-induced late asthmatic response as measured by the AUC of FEV1 from 3 to 7 hours post-allergen challenge | 7 hours |
| Measure | Description | Time Frame |
|---|---|---|
| At 24 hours post-allergen challenge; treatment comparison of allergen-induced changes from baseline in sputum eosinophils and metachromatic cells | 72 hours | |
| Allergen-induced airway responsiveness 24 hours post-allergen challenge as primary interest; 72 hour assessment timepoint will be supportive |
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Inclusion Criteria:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Henk-Andre Kroon, MD | Alexion Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada | ||
| Hospital Laval |
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| ID | Term |
|---|---|
| C481642 | eculizumab |
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| 72 hours |
| Maximum % decrease in FEV1 from 3 to 7 hours post-allergen challenge | 7 hours |
| % decrease of FEV1 at 24 hours post-allergen challenge | 24 hours |
| AUC and maximum % fall of FEV1 from 0-3 hours post-allergen challenge | 3 hours |
| Ste-Foy |
| Quebec |
| G1V 4G5 |
| Canada |