Pilot Study of Statin Treatment in Patients With Stable Moderate to Severe Asthma
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Queen's University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- PC20 Methacholine dose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Atorvastatin
Intervention: Atorvastatin (Drug)
2
Placebo Pill
Intervention: Atorvastatin (Drug)
Outcomes
Primary Outcomes
PC20 Methacholine dose
Time Frame: 4 weeks
Secondary Outcomes
- MiniAQLQ score (an asthma specific quality of life)(4 weeks)
- liver enzymes(4 weeks)
- Post bronchodilator FEV1(4 weeks)
- daily dose of inhaled corticosteroid in beclomethasone disposable equivalents(4 weeks)
- sputum eosinophil count(4 weeks)
- number of exacerbations or infections over the study period(4 weeks)
Investigators
Dr. Diane Lougheed
Professor, Department of Medicine
Queen's University