Asthma
Conditions
Keywords
Asthma, Statin
Brief summary
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
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.
Interventions
DRUGAtorvastatin
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.
Sponsors
The Physicians' Services Incorporated Foundation
Ontario Lung Association
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PC20 Methacholine dose | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| sputum eosinophil count | 4 weeks |
| daily dose of inhaled corticosteroid in beclomethasone disposable equivalents | 4 weeks |
| Post bronchodilator FEV1 | 4 weeks |
| MiniAQLQ score (an asthma specific quality of life) | 4 weeks |
| liver enzymes | 4 weeks |
| number of exacerbations or infections over the study period | 4 weeks |
Countries
Canada
Outcome results
None listed