Statin Treatment in Patients With Asthma - Full Text View

Sponsors and Collaborators:	Queen's University The Physicians' Services Incorporated Foundation Ontario Lung Association
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00292201

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Atorvastatin	Phase II

MedlinePlus related topics: Asthma Statins

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Pilot Study of Statin Treatment in Patients With Stable Moderate to Severe Asthma

Further study details as provided by Queen's University:

Primary Outcome Measures:

PC20 Methacholine dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	45
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Atorvastatin	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.
2: Placebo Comparator Placebo Pill	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.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292201

Locations

Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V6

Sponsors and Collaborators

Queen's University

The Physicians' Services Incorporated Foundation

Ontario Lung Association

Investigators

Principal Investigator:

Diane Lougheed, MD

Queen's University

More Information

Publications:

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. Review.

Weitz-Schmidt G. Statins as anti-inflammatory agents. Trends Pharmacol Sci. 2002 Oct;23(10):482-6. Review.

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. No abstract available.

Responsible Party:	Queen's University ( Dr. Diane Lougheed )
Study ID Numbers:	120973
Study First Received:	February 14, 2006
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00292201 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

Asthma
Statin

Study placed in the following topic categories:

Antimetabolites
Bronchial Diseases
Antilipemic Agents
Asthma
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Atorvastatin
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Immune System Diseases
Antilipemic Agents
Asthma
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Atorvastatin
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009