Clinical trial NCT00292201: Statin Treatment in Patients With Asthma
Official title: Pilot Study of Statin Treatment in Patients With Stable Moderate to Severe Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Statin
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
name: Ontario Lung Association
First posted: 2006-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PC20 Methacholine dose
timeFrame: 4 weeks
Secondary outcomes:
measure: Post bronchodilator FEV1
timeFrame: 4 weeks
measure: sputum eosinophil count
timeFrame: 4 weeks
measure: daily dose of inhaled corticosteroid in beclomethasone disposable equivalents
timeFrame: 4 weeks
measure: number of exacerbations or infections over the study period
timeFrame: 4 weeks
measure: MiniAQLQ score (an asthma specific quality of life)
timeFrame: 4 weeks
measure: liver enzymes
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Diane Lougheed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boulet LP, Becker A, Berube D, Beveridge R, Ernst P. Canadian Asthma Consensus Report, 1999. Canadian Asthma Consensus Group. CMAJ. 1999 Nov 30;161(11 Suppl):S1-61.
citation: Weitz-Schmidt G. Statins as anti-inflammatory agents. Trends Pharmacol Sci. 2002 Oct;23(10):482-6. doi: 10.1016/s0165-6147(02)02077-1.
citation: Pasternak RC, Smith SC Jr, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C; American College of Cardiology; American Heart Association; National Heart, Lung and Blood Institute. ACC/AHA/NHLBI Clinical Advisory on the Use and Safety of Statins. Circulation. 2002 Aug 20;106(8):1024-8. doi: 10.1161/01.cir.0000032466.44170.44. No abstract available.