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| Sponsor: | MedImmune LLC |
|---|---|
| Information provided by (Responsible Party): | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00768079 |
Purpose
The study will evaluate the effect of two IV dose regimens of MEDI-563 on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Biological: MEDI-563 Other: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Double-blind, Placebocontrolled Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563, A Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, on Asthma Control Following Acute Exacerbations in Adults |
| Enrollment: | 110 |
| Study Start Date: | February 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
MEDI-563
|
Biological: MEDI-563
0.3 mg/kg IV MEDI-563 on Study Day 0
|
|
Experimental: 2
MEDI-563
|
Biological: MEDI-563
1.0 mg/kg IV MEDI-563 on Study Day 0
|
|
3
Placebo
|
Other: Placebo
Placebo on Study Day 0 (3mL vials filled with 1.2 mL solution of 10mM histidine, 300 mM glycine, 0.02% polysorbate 20, pH 6.0.)
|
The study will evaluate the effect of two IV dose regimens of MEDI-563 (0.3 and 1.0 mg/kg) on the proportion of adult subjects with asthma exacerbations (relapse and de novo) who required an urgent healthcare visit for treatment of an acute asthma exacerbation.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Univ. of South Florida (Asthma, Allergy & Immunology Clinical Res.Unit) | |
| Tampa, Florida, United States, 33613 | |
| United States, Massachusetts | |
| Baystate Emergency Medicine | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Henry Ford Hospital; Dept. of Emergency Medicine | |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| Nassau Univ. Medical Center | |
| East Meadow, New York, United States, 11554 | |
| Long Island Jewish Medical Center, Dept. of Emergency Medicine | |
| New Hyde Park, New York, United States, 11040-1496 | |
| Research Site | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Research Site | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| Emergency Medicine Research Center- Summa Health System | |
| Akron, Ohio, United States, 44309 | |
| Research Site | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Pennsylvania | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Canada, Alberta | |
| Research Site | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, Nova Scotia | |
| Capital District Health Authority | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Research Site | |
| Kingston, Ontario, Canada | |
| Study Director: | Joseph M. Parker, M.D. | MedImmune LLC |
More Information
| Responsible Party: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00768079 History of Changes |
| Other Study ID Numbers: | MI-CP186 |
| Study First Received: | October 3, 2008 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |