search
Back to results

Statin Treatment in Patients With Asthma

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Statin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Atorvastatin

Placebo Pill

Outcomes

Primary Outcome Measures

PC20 Methacholine dose

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2006
Last Updated
September 14, 2015
Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation, Ontario Lung Association
search

1. Study Identification

Unique Protocol Identification Number
NCT00292201
Brief Title
Statin Treatment in Patients With Asthma
Official Title
Pilot Study of Statin Treatment in Patients With Stable Moderate to Severe Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding to complete subject recruitment and testing
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation, Ontario Lung Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Statin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Atorvastatin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo Pill
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
PC20 Methacholine dose
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Post bronchodilator FEV1
Time Frame
4 weeks
Title
sputum eosinophil count
Time Frame
4 weeks
Title
daily dose of inhaled corticosteroid in beclomethasone disposable equivalents
Time Frame
4 weeks
Title
number of exacerbations or infections over the study period
Time Frame
4 weeks
Title
MiniAQLQ score (an asthma specific quality of life)
Time Frame
4 weeks
Title
liver enzymes
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Lougheed, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10906907
Citation
Boulet LP, Becker A, Berube D, Beveridge R, Ernst P. Canadian Asthma Consensus Report, 1999. Canadian Asthma Consensus Group. CMAJ. 1999 Nov 30;161(11 Suppl):S1-61.
Results Reference
background
PubMed Identifier
12368073
Citation
Weitz-Schmidt G. Statins as anti-inflammatory agents. Trends Pharmacol Sci. 2002 Oct;23(10):482-6. doi: 10.1016/s0165-6147(02)02077-1.
Results Reference
background
PubMed Identifier
12186811
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. doi: 10.1161/01.cir.0000032466.44170.44. No abstract available.
Results Reference
background

Learn more about this trial

Statin Treatment in Patients With Asthma

We'll reach out to this number within 24 hrs