Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)
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This study will test whether lovastatin helps to modify lung inflammation in patients with COPD (Chronic Obstructive Pulmonary Disease).
Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)
Drug: LovastatinDrug: Placebo
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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Ages Eligible for Study:
45 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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.