Trial to Evaluate the Effect of Statins on Asthma Control of Patients With Chronic Asthma
Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
Summary
Statins are the most common type of cholesterol-lowering drugs used in clinical practice.
Recent research suggests that they may also have anti-inflammatory properties, in particular
by inhibition of an important inflammatory cell called a T lymphocyte. Asthma is
characterised by chronic inflammation in the airways, which is thought to be regulated by the
activity of T lymphocytes. The investigators have found the anti-inflammatory activity of a
statin drug in an experimental model of allergic asthma and they have recently shown the
beneficial effects of a statin, atorvastatin, in patients with rheumatoid arthritis. These
findings demonstrate the therapeutic potential of statin-sensitive pathways in allergic
airways disease. The investigators plan to perform a "proof of concept" study to determine
the effectiveness of statin therapy in asthma. This randomised controlled trial will test the
hypothesis that statins improve asthma control of patients with chronic asthma. The study
will be a 22-week randomised controlled trial comparing the effect on asthma control of oral
atorvastatin with that of a matched placebo. Each treatment will be administered for 8 weeks
separated by a 6-week washout period. A total of 52 allergic asthmatic patients will be
recruited to ensure that 44 patients complete the study. The investigators will examine the
effect of statin therapy on lung function, symptom scores, exacerbation rates, as well as on
the measurement of airway inflammation in sputum and in the blood. This study will determine
the benefit of atorvastatin as an add-on therapy in asthma and establish if statins might
have a role in asthma management.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Glasgow
Collaborators:
Asthma UK NHS Greater Clyde and Glasgow NHS Greater Glasgow and Clyde