- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00187499
Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma
April 2, 2008 updated by: University of California, San Francisco
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- Airway Clinical Research Center, Room 1303 Moffitt, UCSF Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Methacholine responsiveness
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Secondary Outcome Measures
Outcome Measure |
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lung function
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gene expression in brushed epithelial cells
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John V Fahy, M.D., University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Study Completion
February 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
April 3, 2008
Last Update Submitted That Met QC Criteria
April 2, 2008
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
Other Study ID Numbers
- H6788-20160-04
- P50HL056385 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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