Status:
COMPLETED
Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
National Jewish Health
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
45+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00700921
Start Date
April 1 2008
End Date
November 1 2012
Last Update
January 19 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206