Statin Treatment in Patients With Asthma

Study Overview
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Brief Summary
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Asthma is a chronic respiratory condition characterized by bronchial hyper-responsiveness secondary to abnormal inflammation of the lung. Steroids remain the most effective treatment for this condition. The lipid lowering agents statins have been found to have anti-inflammatory properties. This study is to test the hypothesize that statins will decrease bronchial hyperresponsiveness and inflammation, leading to improved symptoms in patients with asthma.

Detailed Description
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Asthma affects 7 - 12 % of the population in North America and results in substantial morbidity and health care costs. Management of asthma is focused towards reducing airway inflammation through a combination of avoidance of inciting and triggering pro-inflammatory agents as well as anti-inflammatory medication. Corticosteroids and anti-leukotrienes are efficacious, but are neither universally effective nor free of side effects. Statins, which are currently widely prescribed and used safely to improve serum lipids and cholesterol, have anti-inflammatory properties which may be clinically useful in asthma either in addition to or perhaps instead of corticosteroids. The objective of this research proposal is to conduct a randomized placebo controlled trial of 4 weeks statin therapy in patients in moderate to severe but stable asthma. We hypothesize that statins may directly reduce airway inflammation and/or contribute to the anti-inflammatory effects of corticosteroid treatment in these patients. We will measure the effects of statins by measuring airway sensitivity to methacholine, pulmonary function, sputum eosinophils, and quality of life in subjects with asthma after 4 weeks of treatment. Statins may become an alternative treatment option or act as steroid sparing agents in patients with asthma.

Official Title
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Pilot Study of Statin Treatment in Patients With Stable Moderate to Severe Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Moderate to severe asthma based on Canadian Asthma Consensus Report Objective evidence of airway hyper-responsiveness (reversible airflow obstruction or positive methacholine challenge in previous two years On chronic maintenance inhaled corticosteroid therapy. Exclusion Criteria: Asthma exacerbation within preceding 3 months necessitating any escalation of maintenance medications Chronic oral prednisone use Other respiratory, inflammatory and autoimmune disorder Abnormal baseline creatinine kinase, liver transaminases, or renal disease History of coronary artery disease, hyperlipidemia, or other condition requiring statin therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Atorvastatin | Drug: Atorvastatin<br>* The treatment group will receive Atorvastatin 80 mg po once per day for 4 weeks. The placebo group will receive an identical placebo pill po once per day for 4 weeks.<br>* Other names: Lipitor;|
| Placebo Comparator: 2<br>Placebo Pill | Drug: Atorvastatin<br>* The treatment group will receive Atorvastatin 80 mg po once per day for 4 weeks. The placebo group will receive an identical placebo pill po once per day for 4 weeks.<br>* Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PC20 Methacholine dose |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post bronchodilator FEV1 |  | 4 weeks | 
| sputum eosinophil count |  | 4 weeks | 
| daily dose of inhaled corticosteroid in beclomethasone disposable equivalents |  | 4 weeks | 
| number of exacerbations or infections over the study period |  | 4 weeks | 
| MiniAQLQ score (an asthma specific quality of life) |  | 4 weeks | 
| liver enzymes |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Statin