Statin Treatment in Patients With Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Ontario Lung Association
Information provided by (Responsible Party):
Diane Lougheed, Queen's University
ClinicalTrials.gov Identifier:
NCT00292201
First received: February 14, 2006
Last updated: October 26, 2012
Last verified: October 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Statin Treatment in Patients With Stable Moderate to Severe Asthma

Resource links provided by NLM:


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: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Diane Lougheed, Professor, Department of Medicine, Queen's University
ClinicalTrials.gov Identifier: NCT00292201     History of Changes
Other Study ID Numbers: 120973
Study First Received: February 14, 2006
Last Updated: October 26, 2012
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Asthma
Statin

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

ClinicalTrials.gov processed this record on July 23, 2014