Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Lovastatin as a Potential Modulator of Apoptosis in COPD
Verified date | January 2021 |
Source | National Jewish Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will test whether lovastatin helps to modify lung inflammation in patients with COPD (Chronic Obstructive Pulmonary Disease).
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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 if undergoing bronchoscopy, or between 30% and 80% of predicted if undergoing induced sputum only 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), if undergoing bronchoscopy 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. For patients undergoing bronchoscopy, any contraindication to fiberoptic bronchoscopy or conscious sedation, including abnormalities of the platelet count, prothrombin time or partial thromboplastin time. |
Country | Name | City | State |
---|---|---|---|
United States | National Jewish Medical and Research Center | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
National Jewish Health | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages. | 5 years | ||
Secondary | To determine the effects of lovastatin on COPD phenotypic variables including lung function, exercise performance, clinical status and quality of life. | 5 years |
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