Statin Treatment in Patients With Asthma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- PC20 Methacholine dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- 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 |
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| Canada, Ontario | |
| Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 2V6 | |
| 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 June 17, 2013