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

February 14, 2006
October 26, 2012
February 2006
June 2013   (final data collection date for primary outcome measure)
PC20 Methacholine dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
PC20 Methacholine dose
Complete list of historical versions of study NCT00292201 on ClinicalTrials.gov Archive Site
  • 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 ]
Post bronchodilator FEV1, sputum eosinophil count, daily dose of inhaled corticosteroid in beclamethasone disposable equivalents, number of exacerbations or infections over the study period, and MiniAQLQ score (an asthma specific quality of l
Not Provided
Not Provided
 
Statin Treatment in Patients With Asthma
Pilot Study of Statin Treatment in Patients With Stable Moderate to Severe Asthma

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
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
  • Experimental: 1
    Atorvastatin
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: 2
    Placebo Pill
    Intervention: Drug: Atorvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00292201
120973
No
Diane Lougheed, Queen's University
Queen's University
  • The Physicians' Services Incorporated Foundation
  • Ontario Lung Association
Principal Investigator: Diane Lougheed, MD Queen's University
Queen's University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP