Statin Treatment in Patients With Asthma

Queen's University

Status and phase

Terminated

Phase 2

Conditions

Asthma

Treatments

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00292201

120973

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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