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

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

Detailed Description
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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.

Official Title
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Lovastatin as a Potential Modulator of Apoptosis in COPD

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Lovastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥45 years) former smokers with ≥ 10 pack-years of cigarette smoking FEV1/FVC ratio < 70% Post-bronchodilator FEV1 between 50% and 80% of predicted if undergoing bronchoscopy, or between 30% and 80% of predicted if undergoing induced sputum only DLco/VA < 80% predicted Ability to perform and adhere to study protocol ability to provide informed consent. Exclusion Criteria: Asthma or other comorbid lung disease, Hypoxemia (PaO2 < 55 mmHg or SpO2 < 88% on room air), if undergoing bronchoscopy Exacerbation of COPD within the last 6 weeks Upper or lower respiratory tract infection within the last 6 weeks Current smoking Significant coronary artery disease as reflected by unstable angina, myocardial infarction or angioplasty/stenting/bypass surgery within 6 months Current use of HMG-coA-reductase inhibitors Current use of inhaled corticosteroid Concurrent use of other Cyp3A4 (isoform of cytochrome P450) inhibitors History of adverse reaction to HMG-coA-reductase inhibitors (rhabdomyolysis, hepatitis) For patients undergoing bronchoscopy, any contraindication to fiberoptic bronchoscopy or conscious sedation, including abnormalities of the platelet count, prothrombin time or partial thromboplastin time.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Drug (Lovastatin)<br> | Drug: Lovastatin<br>* 40mg po once daily<br>|
| Placebo Comparator: Placebo (inactive comparator)<br> | Drug: Placebo<br>* One capsule, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of lovastatin on COPD phenotypic variables including lung function, exercise performance, clinical status and quality of life. |  | 5 years |