Statin Treatment in Patients With Asthma

September 14, 2015 updated by: Dr. Diane Lougheed, Queen's University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V6
        • Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PC20 Methacholine dose
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Post bronchodilator FEV1
Time Frame: 4 weeks
4 weeks
sputum eosinophil count
Time Frame: 4 weeks
4 weeks
daily dose of inhaled corticosteroid in beclomethasone disposable equivalents
Time Frame: 4 weeks
4 weeks
number of exacerbations or infections over the study period
Time Frame: 4 weeks
4 weeks
MiniAQLQ score (an asthma specific quality of life)
Time Frame: 4 weeks
4 weeks
liver enzymes
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

The Physicians' Services Incorporated Foundation
Ontario Lung Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (ESTIMATE)

February 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120973

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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