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| Sponsor: | Washington University School of Medicine |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00784459 |
Purpose
This study is designed to determine if treatment with abatacept is effective in decreasing allergic airway inflammation in mild, atopic asthmatics. Subjects will be recruited from the greater St Louis Metropolitan area. Eligible individuals will undergo a titrated skin prick test. Following baseline evaluation, fiberoptic bronchoscopy with segmental allergen challenge (SAC) will be performed. The subjects will be randomized to either placebo or abatacept. After 12 weeks of study drug, the subjects will undergo repeat SAC. The primary endpoint will be to determine if treatment with abatacept results in a 50% or greater decrease in the percentage of eosinophils recovered in the bronchoalveolar lavage (BAL) fluid following SAC as compared to placebo control. Secondary endpoints include measures of airway obstruction and hyperreactivity, airway inflammation and symptoms as well as determination of the safety of abatacept administration in this subject population.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Asthma |
Drug: abatacept Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science |
| Official Title: | Costimulation Inhibition in Asthma |
| Estimated Enrollment: | 24 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment with Abatacept |
Drug: abatacept
Treatment with abatacept, 10 mg/kg IV, for 5 doses.
Other Names:
|
| Placebo Comparator: Placebo |
Drug: Placebo
Treatment with Placebo, IV
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all of the following criteria:
Exclusion Criteria:
Patients must have none of the following:
Contacts and Locations| Contact: Brenda Patterson, MSN, RN, FNP | 314-362-3849 | bxpatter@dom.wustl.edu |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| saint Louis, Missouri, United States, 63110 | |
| Contact: Brenda Patterson, MSN, RN, FNP 314-362-3849 | |
| Principal Investigator: | Jonathan Green, MD | Washington University School of Medicine |
More Information
| Responsible Party: | Jonathan M Green, MD, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00784459 History of Changes |
| Other Study ID Numbers: | 08-0405 |
| Study First Received: | November 3, 2008 |
| Last Updated: | March 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Allergy |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Abatacept Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |