Effect of Statins on Asthma Control in Smokers With Asthma

Phase 2

Completed

• Conditions: Asthma; COPD; Smoking
• Interventions: Drug: matched placebo; Drug: atorvastatin

• Registration Number: NCT00463827
• Lead Sponsor: NHS Greater Clyde and Glasgow

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.

Study Timeline

• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-18
• Study First Posted: 2007-04-20
• Study Start: 2007-08
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	matched placebo	matched placebo
2	atorvastatin	Atorvastatin 40

Primary Outcome Measures

Name	Time	Method
Change in peak flow data	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gartnavel General Hospital; 🇬🇧 Glasgow, United Kingdom