Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00187499
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 3, 2008
Sandler Family Supporting Foundation
Information provided by:
University of California, San Francisco

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 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Inhaled fluticasone 500 ug BID for 8 weeks Not Applicable

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 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma
Study Start Date : October 2002
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Fluticasone
U.S. FDA Resources

Primary Outcome Measures :
  1. Methacholine responsiveness

Secondary Outcome Measures :
  1. gene expression in brushed epithelial cells
  2. lung function

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00187499

United States, California
Airway Clinical Research Center, Room 1303 Moffitt, UCSF Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Sandler Family Supporting Foundation
Principal Investigator: John V Fahy, M.D. University of California, San Francisco

Additional Information: Identifier: NCT00187499     History of Changes
Other Study ID Numbers: H6788-20160-04
P50HL056385 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: September 2005

Keywords provided by University of California, San Francisco:
Gene expression

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents