NCT00292201

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

7.3 years

First QC Date

February 14, 2006

Last Update Submit

September 14, 2015

Conditions

Asthma

Keywords

AsthmaStatin

Outcome Measures

Primary Outcomes (1)

  • PC20 Methacholine dose

    4 weeks

Secondary Outcomes (6)

  • Post bronchodilator FEV1

    4 weeks

  • sputum eosinophil count

    4 weeks

  • daily dose of inhaled corticosteroid in beclomethasone disposable equivalents

    4 weeks

  • number of exacerbations or infections over the study period

    4 weeks

  • MiniAQLQ score (an asthma specific quality of life)

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Atorvastatin

Drug: Atorvastatin

2

PLACEBO COMPARATOR

Placebo Pill

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

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.

Also known as: Lipitor
12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V6, Canada

Location

Related Publications (3)

  • 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.

    PMID: 10906907BACKGROUND

  • 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.

    PMID: 12368073BACKGROUND

  • 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.

    PMID: 12186811BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Diane Lougheed, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Medicine

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 15, 2006

Study Start

February 1, 2006

Primary Completion

June 1, 2013

Study Completion

June 1, 2015

Last Updated

September 16, 2015

Record last verified: 2015-09

Locations

CA(1)