AsthmaNCT00187499
Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma
A study testing Inhaled fluticasone 500 ug BID for 8 weeks in people with Asthma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Inhaled fluticasone 500 ug BID for 8 weeks
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Feb 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Airway Clinical Research Center, Room 1303 Moffitt, UCSF Medical Center
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Inhaled fluticasone 500 ug BID for 8 weeks
- Keywords
- Asthma, Corticosteroid, Gene expression
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled fluticasone 500 ug BID for 8 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine responsiveness
Secondary outcomes (2)
gene expression in brushed epithelial cells
lung function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2002
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Sandler Family Supporting Foundation
- Investigators
- John V Fahy, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187499
- Sponsor's protocol ID
- H6788-20160-04
- Other IDs
- P50HL056385
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 3 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma
- ClinicalTrials.gov ID
- NCT00187499
- Acronym / sponsor ID
- H6788-20160-04
- Conditions
- Asthma
- Keywords
- Asthma, Corticosteroid, Gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Sandler Family Supporting Foundation
- Study start
- Oct 2002
- Study completion
- Feb 2005
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled fluticasone 500 ug BID for 8 weeks | Drug | – |
Primary outcome
Methacholine responsiveness
2 secondary outcomes
gene expression in brushed epithelial cells
lung function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
- website for the asthma clinical research group at UCSFLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John V Fahy, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled fluticasone 500 ug BID for 8 weeks in people with Asthma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methacholine responsiveness. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2008.