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

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
E Rand Sutherland, National Jewish Health Identifier:
First received: June 17, 2008
Last updated: November 26, 2012
Last verified: November 2012
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lovastatin as a Potential Modulator of Apoptosis in COPD

Resource links provided by NLM:

Further study details as provided by E Rand Sutherland, National Jewish Health:

Primary Outcome Measures:
  • To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages. [ Time Frame: 5 years ]

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 ]

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.

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00700921

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)
Principal Investigator: E Rand Sutherland, MD, MPH National Jewish Health
  More Information

Responsible Party: E Rand Sutherland, Chair of Pulmonary Medicine, National Jewish Health 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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
L 647318
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on September 19, 2017