Gartnavel General Hospital
Glasgow, G12 0YN, United Kingdom
NCT Number: NCT00463827
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Glasgow, G12 0YN, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note separate entry criteria for pilot study of COPD patients
Matched placebo
Time frame: 4 weeks
Time frame: 4 weeks and 8 weeks
Time frame: 4 weeks and 8 weeks
Time frame: 4 weeks and 8 weeks
Time frame: 4 weeks and 8 weeks
Time frame: 4 weeks and 8 weeks
Time frame: 4 and 8 weeks
Time frame: 4 and 8 weeks
Time frame: 4 and 8 weeks
Time frame: 4 and 8 weeks
Time frame: 4 and 8 weeks
NHS Greater Clyde and Glasgow
Other
Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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