Asthma, COPD, Smoking
Conditions
Keywords
asthma, smokers, statin, atorvastatin, randomised, placebo, cigarette, blind, COPD
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.
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 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.
Interventions
atorvastatin 40mg
Matched placebo
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak flow data | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| sputum cell counts | 4 weeks 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 |
| Exacerbation rates | 4 and 8 weeks |
Countries
United Kingdom