Status:
COMPLETED
Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Sandler Family Supporting Foundation
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 de...
Detailed Description
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 express...
Eligibility Criteria
Inclusion
- Male and female patients with a history of asthma between the ages of 18 and 70 years.
- PC20FEV1 Methacholine ≤ 8.0 mg/mL.
- At least one of the following symptoms, beta agonist use, or FEV1 criteria:
- Asthma symptoms on at least two days per week or Beta agonist use on at least two days per week or FEV1 \< 85% predicted
- Subjects must be non-smokers (patients who have never smoked or patients who have not smoked for 1 year and have a total pack-year smoking history \< 15 packs).
Exclusion
- History of oral or inhaled steroid use in the past 4 weeks.
- FEV1 \< 60% predicted.
- Lung disease other than asthma.
- Patients with a history of a respiratory tract infection in the 4 weeks preceding the study.
- Patients who have experienced a significant exacerbation in their asthma in the 6 weeks prior to the study.
- Patients receiving hyposensitization therapy with the exception of those who are on a stable dose for the last three months.
- Patients with cardiovascular disease (active) peptic ulcer disease or diabetes mellitus.
- Females who are lactating or who are pregnant.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00187499
Start Date
October 1 2002
End Date
February 1 2005
Last Update
April 3 2008
Active Locations (1)
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1
Airway Clinical Research Center, Room 1303 Moffitt, UCSF Medical Center
San Francisco, California, United States, 94143