NCT00700921CompletedPhase 2
Lovastatin as a Potential Modulator of Apoptosis in COPD
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- National Jewish Health
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages.
Study Overview
Brief Summary
This study will test whether lovastatin helps to modify lung inflammation in patients with COPD (Chronic Obstructive Pulmonary Disease).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Active Drug (Lovastatin)
Experimental
Intervention: Lovastatin (Drug)
Placebo (inactive comparator)
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages.
Time Frame: 5 years
Secondary Outcomes
- To determine the effects of lovastatin on COPD phenotypic variables including lung function, exercise performance, clinical status and quality of life.(5 years)
Investigators
Study Sites (1)
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