NCT00463827

Effect of Statins on Asthma Control in Smokers With Asthma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: NHS Greater Clyde and Glasgow · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• COPD
• Smoking

Interventions

Type	Name	Description
DRUG	Atorvastatin
DRUG	atorvastatin	atorvastatin 40mg
DRUG	matched placebo	Matched placebo

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-04-20
• Last updated: 2017-03-28

Locations

1 site across 1 country: United Kingdom