Effect of Statins on Asthma Control in Smokers With Asthma

• 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 ]

• sputum cell counts
• spirometry
• airway responsiveness to methacholine
• symptom scores
• Exhaled and alveolar NO
• Exacerbation rates
• immunological tests in blood

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.

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.

• Asthma
• COPD
• Smoking

• Drug: Atorvastatin
• Drug: atorvastatin
  atorvastatin 40mg
• Drug: matched placebo
  Matched placebo

• Active Comparator: 2
  Atorvastatin 40
  Interventions:

  • Drug: Atorvastatin
  • Drug: atorvastatin
• Placebo Comparator: placebo
  matched placebo
  Intervention: Drug: matched placebo

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

• University of Glasgow
• Medical Research Council