Official Title: “Lovastatin as a Potential Modulator of Apoptosis in COPD”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2012

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.

Intervention(s) in this Clinical Trial

• Drug: Lovastatin
  • 40mg po once daily
• Drug: Placebo
  • One capsule, once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Lovastatin
• Placebo Comparator: 2
  • Placebo

Primary Measures

• To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages.
  • Time Frame: 5 years
    Safety Issue?: No

Secondary 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
    Safety Issue?: 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
• 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)
• 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. Any contraindication to fiberoptic bronchoscopy or conscious sedation, including abnormalities of the platelet count, prothrombin time or partial thromboplastin time.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Jewish Medical and Research Center

Overall Clinical Trial Officials and Contacts

E Rand Sutherland, MD, MPH Principal Investigator National Jewish Medical and Research Center  

Overall Contact: Jennifer M Brandorff, BA, CIM 303-398-1443 brandorffj@njc.org

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00700921

Study ID Number: NJMRC HS-2163

ClinicalTrials.gov Identifier: NCT00700921

Health Authority: United States: Institutional Review Board