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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Atorvastatin
• Placebo Comparator: 2
  • Placebo Pill

Primary Measures

• PC20 Methacholine dose
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Post bronchodilator FEV1
  • Time Frame: 4 weeks
    Safety Issue?: No
• sputum eosinophil count
  • Time Frame: 4 weeks
    Safety Issue?: No
• daily dose of inhaled corticosteroid in beclomethasone disposable equivalents
  • Time Frame: 4 weeks
    Safety Issue?: No
• number of exacerbations or infections over the study period
  • Time Frame: 4 weeks
    Safety Issue?: No
• MiniAQLQ score (an asthma specific quality of life)
  • Time Frame: 4 weeks
    Safety Issue?: No
• liver enzymes
  • Time Frame: 4 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Queen's University

Overall Clinical Trial Officials and Contacts

Diane Lougheed, MD Principal Investigator Queen's University  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00292201

Study ID Number: 120973

ClinicalTrials.gov Identifier: NCT00292201

Health Authority: Canada: Health Canada