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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Jewish Health
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Dihydromevinolin; L 647318; Lovastatin

Criteria

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.