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

National Jewish Health

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: Lovastatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00700921

NJMRC HS-2163

NIH grant #HL088138

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Active Drug (Lovastatin)

Experimental group

Treatment:

Drug: Lovastatin

Placebo (inactive comparator)

Placebo Comparator group

Treatment:

Drug: Placebo