Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463827
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2007-04-18
Brief Title:
Effect of Statins on Asthma Control in Smokers With Asthma
Sponsor:
NHS Greater Clyde and Glasgow
Organization:
NHS Greater Clyde and Glasgow
Study Overview
Official Title:
Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma a Randomised Controlled Double-blind Parallel Group Study
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Asthma is a chronic inflammatory condition of the lungs
There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with asthma do not respond as well to standard therapies as non-smokers
Statins are drugs which are already used to lower cholesterol They have also been shown to have some anti-inflammatory properties
In this trial the investigators will give a randomised group of smokers Atorvastatin and the remaining group a placebo or blank tablet The investigators will then monitor patients responses in terms of peak flow data symptom diaries questionnaires and breathing tests
There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with asthma do not respond as well to standard therapies as non-smokers
Statins are drugs which are already used to lower cholesterol They have also been shown to have some anti-inflammatory properties
In this trial the investigators will give a randomised group of smokers Atorvastatin and the remaining group a placebo or blank tablet The investigators will then monitor patients responses in terms of peak flow data symptom diaries questionnaires and breathing tests
Detailed Description:
Despite several studies which have shown that smokers with asthma have more severe symptoms accelerated decline in lung function and diminished response to treatment with inhaled and oral corticosteroids more than 25 of asthmatics continue to smoke Smoking cessation advice is often ineffective
Statins are used as cholesterol lowering agents however there is now also evidence that they have additional anti-inflammatory effects which may be useful in treatment of smokers with asthma
This is a randomised placebo controlled double-blind parallel group study
Following screening to assess suitability for the study patients will be randomised to treatment with either Atorvastatin 40mg or placebo blank tabletfor 8 weeks
After 4 weeks of treatment all patients will be commenced on a low dose inhaled corticosteroid for the remainder of the study to assess whether treatment with statins can overcome steroid resistance in smokers with asthma
Statins are used as cholesterol lowering agents however there is now also evidence that they have additional anti-inflammatory effects which may be useful in treatment of smokers with asthma
This is a randomised placebo controlled double-blind parallel group study
Following screening to assess suitability for the study patients will be randomised to treatment with either Atorvastatin 40mg or placebo blank tabletfor 8 weeks
After 4 weeks of treatment all patients will be commenced on a low dose inhaled corticosteroid for the remainder of the study to assess whether treatment with statins can overcome steroid resistance in smokers with asthma
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