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Effect of Statins on Asthma Control in Smokers With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00463827
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : March 28, 2017
University of Glasgow
Medical Research Council
Information provided by (Responsible Party):
Neil Thomson, 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.

Condition or disease Intervention/treatment Phase
Asthma COPD Smoking Drug: Atorvastatin Drug: atorvastatin Drug: matched placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study
Study Start Date : August 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 2
Atorvastatin 40
Drug: Atorvastatin
Drug: atorvastatin
atorvastatin 40mg

Placebo Comparator: placebo
matched placebo
Drug: matched placebo
Matched placebo

Primary Outcome Measures :
  1. Change in peak flow data [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. sputum cell counts [ Time Frame: 4 weeks and 8 weeks ]
  2. spirometry [ Time Frame: 4 weeks and 8 weeks ]
  3. airway responsiveness to methacholine [ Time Frame: 4 weeks and 8 weeks ]
  4. symptom scores [ Time Frame: 4 weeks and 8 weeks ]
  5. Exhaled and alveolar NO [ Time Frame: 4 weeks and 8 weeks ]
  6. Exacerbation rates [ Time Frame: 4 and 8 weeks ]
  7. immunological tests in blood [ Time Frame: 4 and 8 weeks ]
  8. ACQ score [ Time Frame: 4 and 8 weeks ]
  9. AQLQ score [ Time Frame: 4 and 8 weeks ]
  10. Safety issues [ Time Frame: 4 and 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00463827

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United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
NHS Greater Clyde and Glasgow
University of Glasgow
Medical Research Council
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Principal Investigator: Neil Thomson, FRCP University of Glasgow

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Neil Thomson, Professor of Respiratory Medicine, NHS Greater Clyde and Glasgow Identifier: NCT00463827    
Other Study ID Numbers: AR 003
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Neil Thomson, NHS Greater Clyde and Glasgow:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors