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

Lovastatin as a Potential Modulator of Apoptosis in COPD

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00700921

Enrollment

Registered

2008-06-19

Start date

2008-04-30

Completion date

2012-11-30

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

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.

Interventions

DRUGLovastatin

40mg po once daily

DRUGPlacebo

One capsule, once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026