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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00700921
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : January 19, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Jewish Health

Tracking Information
First Submitted Date  ICMJE June 17, 2008
First Posted Date  ICMJE June 19, 2008
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE April 2008
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages. [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE Lovastatin as a Potential Modulator of Apoptosis in 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: Lovastatin
    40mg po once daily
  • Drug: Placebo
    One capsule, once daily
Study Arms  ICMJE
  • Experimental: Active Drug (Lovastatin)
    Intervention: Drug: Lovastatin
  • Placebo Comparator: Placebo (inactive comparator)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2012)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2008)
44
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00700921
Other Study ID Numbers  ICMJE NJMRC HS-2163
NIH grant #HL088138
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Jewish Health
Study Sponsor  ICMJE National Jewish Health
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: E Rand Sutherland, MD, MPH National Jewish Health
PRS Account National Jewish Health
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP