Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Sandler Family Supporting Foundation
• Treatments: Fluticasone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.