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Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
E Rand Sutherland, National Jewish Health
ClinicalTrials.gov Identifier:
NCT00700921
First received: June 17, 2008
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

This study will test whether lovastatin helps to modify lung inflammation in patients with COPD (Chronic Obstructive Pulmonary Disease).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: Lovastatin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lovastatin as a Potential Modulator of Apoptosis in COPD

Resource links provided by NLM:

Drug Information available for: Lovastatin
U.S. FDA Resources

Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effects of lovastatin on COPD phenotypic variables including lung function, exercise performance, clinical status and quality of life. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug (Lovastatin) Drug: Lovastatin
40mg po once daily
Placebo Comparator: Placebo (inactive comparator) Drug: Placebo
One capsule, once daily

Detailed Description:

The impact of lovastatin, 40mg by mouth once daily on biological and clinical outcomes will be evaluated in an exploratory 16-week comparative treatment efficacy trial in 44 adult former smokers with established COPD of moderate severity. This trial employs a longitudinal randomized, parallel-arm, double-blind, placebo-controlled design using biomarkers of airway inflammation as the primary outcomes of interest.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (≥45 years) former smokers with ≥ 10 pack-years of cigarette smoking
  2. FEV1/FVC ratio < 70%
  3. Post-bronchodilator FEV1 between 50% and 80% of predicted if undergoing bronchoscopy, or between 30% and 80% of predicted if undergoing induced sputum only
  4. DLco/VA < 80% predicted
  5. Ability to perform and adhere to study protocol
  6. ability to provide informed consent.

Exclusion Criteria:

  1. Asthma or other comorbid lung disease,
  2. Hypoxemia (PaO2 < 55 mmHg or SpO2 < 88% on room air), if undergoing bronchoscopy
  3. Exacerbation of COPD within the last 6 weeks
  4. Upper or lower respiratory tract infection within the last 6 weeks
  5. Current smoking
  6. Significant coronary artery disease as reflected by unstable angina, myocardial infarction or angioplasty/stenting/bypass surgery within 6 months
  7. Current use of HMG-coA-reductase inhibitors
  8. Current use of inhaled corticosteroid
  9. Concurrent use of other Cyp3A4 (isoform of cytochrome P450) inhibitors
  10. History of adverse reaction to HMG-coA-reductase inhibitors (rhabdomyolysis, hepatitis)
  11. For patients undergoing bronchoscopy, any contraindication to fiberoptic bronchoscopy or conscious sedation, including abnormalities of the platelet count, prothrombin time or partial thromboplastin time.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700921

Locations
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: E Rand Sutherland, MD, MPH National Jewish Health
  More Information

No publications provided

Responsible Party: E Rand Sutherland, Chair of Pulmonary Medicine, National Jewish Health
ClinicalTrials.gov Identifier: NCT00700921     History of Changes
Other Study ID Numbers: NJMRC HS-2163, NIH grant #HL088138
Study First Received: June 17, 2008
Last Updated: November 26, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lovastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013