The Effect of Inhibition of B7-mediated Costimulation on Allergic Airway Inflammation in Mild Atopic Asthmatics (CIA)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
|Official Title:||Costimulation Inhibition in Asthma|
- Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge [ Time Frame: baseline ] [ Designated as safety issue: No ]collected prior to randomization to abatacept or placebo
- Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment with Abatacept
Administration of Abatacept intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses.
Treatment with abatacept, 10 mg/kg IV, for 5 doses.
Placebo Comparator: Placebo
Administration of placebo (normal saline) intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses.
Treatment with Placebo, IV
please see summary
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784459
|United States, Missouri|
|Washington University School of Medicine|
|saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Jonathan Green, MD||Washington University Early Recognition Center|