Back to resultsLovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lovastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
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.
Sites / Locations
- National Jewish Medical and Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Drug (Lovastatin)
Placebo (inactive comparator)
Arm Description
Outcomes
Primary Outcome Measures
To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages.
Secondary Outcome Measures
To determine the effects of lovastatin on COPD phenotypic variables including lung function, exercise performance, clinical status and quality of life.
Full Information
NCT ID
NCT00700921
First Posted
June 17, 2008
Last Updated
January 15, 2021
Sponsor
National Jewish Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00700921
Brief Title
Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Lovastatin as a Potential Modulator of Apoptosis in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2008 (Actual)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Drug (Lovastatin)
Arm Type
Experimental
Arm Title
Placebo (inactive comparator)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lovastatin
Intervention Description
40mg po once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One capsule, once daily
Primary Outcome Measure Information:
Title
To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
To determine the effects of lovastatin on COPD phenotypic variables including lung function, exercise performance, clinical status and quality of life.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E Rand Sutherland, MD, MPH
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)
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