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

NCT ID: NCT00700921

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-11-30

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 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Drug (Lovastatin)

Group Type: EXPERIMENTAL

Lovastatin

Intervention Type: DRUG

40mg po once daily

Placebo (inactive comparator)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One capsule, once daily

Interventions

Lovastatin

40mg po once daily

Intervention Type: DRUG

Placebo

One capsule, once daily

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

E Rand Sutherland, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

National Jewish Medical and Research Center

Denver, Colorado, United States

Countries

United States

Other Identifiers

NIH grant #HL088138

Identifier Type: -

Identifier Source: secondary_id

NJMRC HS-2163

Identifier Type: -

Identifier Source: org_study_id