Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma
The purpose of this study is to determine whether an inhaled corticosteroid (fluticasone) alters the expression of any gene expressed in the lining of the airways of asthmatics. The study uses high density gene chips which allow the study investigators to measures all gene in the human genome. We hypothesize that this approach will identify novel genes that are affected by steroids in asthmatics.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma|
- Methacholine responsiveness
- gene expression in brushed epithelial cells
- lung function
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||February 2005|
This is a 10 week, randomized, double blind, prospective study comparing the effects of inhaled fluticasone or inhaled placebo on measures of airway function, airway remodeling and airway gene expression in asthmatic subjects. Enrollment has been completed as have all study visits. We are now in the data analysis phase. The study design was as follows: Following a one-week run-in/characterization period, subjects were randomized to receive 2 puffs BID of fluticasone (250µg/puff) or matching placebo for 8 weeks. Beginning with the run-in period, subjects recordes in a daily diary their peak flow measurements twice daily, (symptoms of cough, sputum production, wheeze, dyspnea, and chest tightness. They visited the laboratory for an interval diary review and spirometry and for medication dispensing. Bronchoscopy was performed at baseline (week 1 of the run-in), and 1 week after starting the study drug Weekly telephone contact will be made during the treatment period to monitor subject well being and to ensure compliance with study medication. There was a one-week run-out to allow monitoring of subjects after discontinuation of the study drug.
|United States, California|
|Airway Clinical Research Center, Room 1303 Moffitt, UCSF Medical Center|
|San Francisco, California, United States, 94143|
|Principal Investigator:||John V Fahy, M.D.||University of California, San Francisco|