NCT00784459

The Effect of Inhibition of B7-mediated Costimulation on Allergic Airway Inflammation in Mild Atopic Asthmatics

Costimulation Inhibition in Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

please see summary

Conditions

• Atopic Asthma

Interventions

Type	Name	Description
DRUG	abatacept	Treatment with abatacept, 10 mg/kg IV, for 5 doses.
DRUG	Placebo	Treatment with Placebo, IV

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2008-11-04
• Last updated: 2014-02-05
• Results posted: 2014-02-05

Locations

1 site across 1 country: United States