Statin Treatment in Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292201
Recruitment Status : Terminated (Lack of funding to complete subject recruitment and testing)
First Posted : February 15, 2006
Last Update Posted : September 16, 2015
The Physicians' Services Incorporated Foundation
Ontario Lung Association
Information provided by (Responsible Party):
Dr. Diane Lougheed, Queen's University

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Atorvastatin Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Statin Treatment in Patients With Stable Moderate to Severe Asthma
Study Start Date : February 2006
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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.
Other Name: Lipitor

Placebo Comparator: 2
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.
Other Name: Lipitor

Primary Outcome Measures :
  1. PC20 Methacholine dose [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Post bronchodilator FEV1 [ Time Frame: 4 weeks ]
  2. sputum eosinophil count [ Time Frame: 4 weeks ]
  3. daily dose of inhaled corticosteroid in beclomethasone disposable equivalents [ Time Frame: 4 weeks ]
  4. number of exacerbations or infections over the study period [ Time Frame: 4 weeks ]
  5. MiniAQLQ score (an asthma specific quality of life) [ Time Frame: 4 weeks ]
  6. liver enzymes [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00292201

Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V6
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Ontario Lung Association
Principal Investigator: Diane Lougheed, MD Queen's University

Responsible Party: Dr. Diane Lougheed, Professor, Department of Medicine, Queen's University Identifier: NCT00292201     History of Changes
Other Study ID Numbers: 120973
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: September 2015

Keywords provided by Dr. Diane Lougheed, Queen's University:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors