Effect of Statins on Asthma Control in Smokers With Asthma
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Asthma COPD Smoking |
Drug: Atorvastatin Drug: atorvastatin Drug: matched placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- Change in peak flow data [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- sputum cell counts [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- spirometry [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- airway responsiveness to methacholine [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- symptom scores [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- Exhaled and alveolar NO [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
- Exacerbation rates [ Time Frame: 4 and 8 weeks ]
- immunological tests in blood [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
- ACQ score [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
- AQLQ score [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
Atorvastatin 40
|
Drug: Atorvastatin
Drug: atorvastatin
atorvastatin 40mg
|
|
Placebo Comparator: placebo
matched placebo
|
Drug: matched placebo
Matched placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United Kingdom | |
| Gartnavel General Hospital | |
| Glasgow, United Kingdom, G12 0YN | |
| Principal Investigator: | Neil Thomson, FRCP | University of Glasgow |
More Information
Additional Information:
No publications provided by NHS Greater Clyde and Glasgow
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Glasgow Biomedicine, NHSGGlasgow |
| ClinicalTrials.gov Identifier: | NCT00463827 History of Changes |
| Other Study ID Numbers: | AR 003 |
| Study First Received: | April 18, 2007 |
| Last Updated: | January 15, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by NHS Greater Clyde and Glasgow:
|
asthma smokers statin atorvastatin randomised |
placebo cigarette blind COPD |
Additional relevant MeSH terms:
|
Asthma Pulmonary Disease, Chronic Obstructive Smoking Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Habits Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013