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

Sponsor

National Jewish Health (Other)

Overall Status

Completed

CT.gov ID

NCT00700921

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Lovastatin Drug: Placebo	Phase 2

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

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Lovastatin as a Potential Modulator of Apoptosis in COPD

Actual Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Drug (Lovastatin)	Drug: Lovastatin 40mg po once daily
Placebo Comparator: Placebo (inactive comparator)	Drug: Placebo One capsule, once daily

Arm

Intervention/Treatment

Experimental: Active Drug (Lovastatin)

Drug: Lovastatin

40mg po once daily

Placebo Comparator: Placebo (inactive comparator)

Drug: Placebo

One capsule, once daily

Outcome Measures

Primary Outcome Measures

To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages. [5 years]

Secondary Outcome Measures

To determine the effects of lovastatin on COPD phenotypic variables including lung function, exercise performance, clinical status and quality of life. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.