Effect of Statins on Asthma Control in Smokers With Asthma
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.
Drug: matched placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study|
- Change in peak flow data [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- sputum cell counts [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- spirometry [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- airway responsiveness to methacholine [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- symptom scores [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- Exhaled and alveolar NO [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- Exacerbation rates [ Time Frame: 4 and 8 weeks ]
- immunological tests in blood [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
- ACQ score [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
- AQLQ score [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 2
Placebo Comparator: placebo
Drug: matched placebo
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 tablet)for 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463827
|Gartnavel General Hospital|
|Glasgow, United Kingdom, G12 0YN|
|Principal Investigator:||Neil Thomson, FRCP||University of Glasgow|