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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Asthma; COPD
• Intervention / Treatment: Drug: Atorvastatin; Drug: matched placebo; Drug: atorvastatin

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G12 0YN
    • Gartnavel General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; matched placebo	Drug: matched placebo; Matched placebo
Active Comparator: 2; Atorvastatin 40	Drug: Atorvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in peak flow data	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: NHS Greater Clyde and Glasgow
• Collaborators: Medical Research Council; University of Glasgow
• Investigators: Principal Investigator: Neil Thomson, FRCP, University of Glasgow

Publications and helpful links

General Publications

• Braganza G, Chaudhuri R, McSharry C, Weir CJ, Donnelly I, Jolly L, Lafferty J, Lloyd SM, Spears M, Mair F, Thomson NC. Effects of short-term treatment with atorvastatin in smokers with asthma--a randomized controlled trial. BMC Pulm Med. 2011 Apr 7;11:16. doi: 10.1186/1471-2466-11-16.

Helpful Links

• Unit website

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 18, 2007
• First Submitted That Met QC Criteria: April 18, 2007
• First Posted (Estimate): April 20, 2007

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: COPD; asthma; placebo; smokers; atorvastatin; statin; cigarette; randomised; blind
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: AR 003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No