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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Lovastatin; Drug: Placebo

• Registration Number: NCT00700921
• Lead Sponsor: National Jewish Health

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Drug (Lovastatin)	Lovastatin	-
Placebo (inactive comparator)	Placebo	-

Primary Outcome Measures

Name	Time	Method
To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages.	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Jewish Medical and Research Center; 🇺🇸 Denver, Colorado, United States