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

NCT00700921 | Completed Phase 2 DMC

• 2 other identifiers: NJMRC HS-2163NIH grant #HL088138
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages.

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (2)

Active Drug (Lovastatin)

EXPERIMENTAL

Drug: Lovastatin

Placebo (inactive comparator)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lovastatin DRUG

40mg po once daily

Active Drug (Lovastatin)

Placebo DRUG

One capsule, once daily

Placebo (inactive comparator)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Jewish Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• E Rand Sutherland, MD, MPH

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)