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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700921
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : January 19, 2021
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Jewish Health

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Lovastatin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Actual Study Start Date : April 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Lovastatin

Arm Intervention/treatment
Experimental: Active Drug (Lovastatin) Drug: Lovastatin
40mg po once daily

Placebo Comparator: Placebo (inactive comparator) Drug: Placebo
One capsule, once daily

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00700921

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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)
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Principal Investigator: E Rand Sutherland, MD, MPH National Jewish Health
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Responsible Party: National Jewish Health Identifier: NCT00700921    
Other Study ID Numbers: NJMRC HS-2163
NIH grant #HL088138
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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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