Effect of Statins on Asthma Control in Smokers With Asthma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study

Conditions
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Asthma, COPD, Smoking

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: atorvastatin
* Drug: matched placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of asthma for more than 1 year Symptomatic asthma Smoker with greater than 5 pack year history On short acting bronchodilator only- although may have medication weaned if stable Exclusion Criteria: Ex-smokers or non-smokers Patients already on statin therapy Unstable asthma Previous statin sensitivity or myopathy or myositis On any medications known to interact with statins Note separate entry criteria for pilot study of COPD patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Atorvastatin 40 | Drug: Atorvastatin<br> <br> Drug: atorvastatin<br>* atorvastatin 40mg<br>|
| Placebo Comparator: placebo<br>matched placebo | Drug: matched placebo<br>* Matched placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak flow data |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum cell counts |  | 4 weeks and 8 weeks | 
| spirometry |  | 4 weeks and 8 weeks | 
| airway responsiveness to methacholine |  | 4 weeks and 8 weeks | 
| symptom scores |  | 4 weeks and 8 weeks | 
| Exhaled and alveolar NO |  | 4 weeks and 8 weeks | 
| Exacerbation rates |  | 4 and 8 weeks | 
| immunological tests in blood |  | 4 and 8 weeks | 
| ACQ score |  | 4 and 8 weeks | 
| AQLQ score |  | 4 and 8 weeks | 
| Safety issues |  | 4 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, smokers, statin, atorvastatin, randomised, placebo, cigarette, blind, COPD