Statin Treatment in Patients With Asthma

Asthma Clinical Trial

Official title:

Pilot Study of Statin Treatment in Patients With Stable Moderate to Severe Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00292201
• Other study ID #: 120973
• Status: Terminated
• Phase: Phase 2
• First received: February 14, 2006
• Last updated: September 14, 2015
• Start date: February 2006
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University	Ontario Lung Association, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Boulet LP, Becker A, Bérubé D, Beveridge R, Ernst P. Canadian Asthma Consensus Report, 1999. Canadian Asthma Consensus Group. CMAJ. 1999 Nov 30;161(11 Suppl):S1-61. Review. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PC20 Methacholine dose		4 weeks	No
Secondary	Post bronchodilator FEV1		4 weeks	No
Secondary	sputum eosinophil count		4 weeks	No
Secondary	daily dose of inhaled corticosteroid in beclomethasone disposable equivalents		4 weeks	No
Secondary	number of exacerbations or infections over the study period		4 weeks	No
Secondary	MiniAQLQ score (an asthma specific quality of life)		4 weeks	No
Secondary	liver enzymes		4 weeks	Yes