Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187499
Status:
COMPLETED
Last Update Posted:
2008-04-03
First Post:
2005-09-13
Brief Title:
Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Effect of an Inhaled Corticosteroid on Airway Gene Expression in Asthma
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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-incharacterization period subjects were randomized to receive 2 puffs BID of fluticasone 250µgpuff 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL056385 | NIH | None | httpsreporternihgovquickSearchP50HL056385 |