Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma

This study has been completed.
Sponsor:
Collaborator:
Sandler Family Supporting Foundation
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187499
First received: September 13, 2005
Last updated: April 2, 2008
Last verified: September 2005
  Purpose

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 Intervention
Asthma
Drug: Inhaled fluticasone 500 ug BID for 8 weeks

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Methacholine responsiveness

Secondary Outcome Measures:
  • gene expression in brushed epithelial cells
  • lung function

Study Start Date: October 2002
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187499

Locations
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
Investigators
Principal Investigator: John V Fahy, M.D. University of California, San Francisco
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00187499     History of Changes
Other Study ID Numbers: H6788-20160-04, P50HL56385
Study First Received: September 13, 2005
Last Updated: April 2, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014