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Losartan Effects on Emphysema Progression (LEEP)

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ClinicalTrials.gov Identifier: NCT02696564
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
JHSPH Center for Clinical Trials

Tracking Information
First Submitted Date  ICMJE February 25, 2016
First Posted Date  ICMJE March 2, 2016
Last Update Posted Date July 11, 2018
Actual Study Start Date  ICMJE May 23, 2017
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
change in mean pct950 [ Time Frame: 48 weeks ]
change in percentage of voxels with density less than -950 Hounsfield Units
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02696564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Losartan Effects on Emphysema Progression
Official Title  ICMJE Losartan Effects on Emphysema Progression
Brief Summary

A randomized, parallel, placebo controlled trial to evaluate the effect of 100mg/day losartan on the progression of emphysema as measured by quantitative HRCT compared to placebo

.

Detailed Description This is a trial designed to test if a treatment, losartan, may decrease the progression of Chronic Obstructive Pulmonary Disease (COPD). Losartan is an angiotensin receptor blocking agent, commonly used as an antihypertensive agent, which has been shown to alter cardiac remodeling after myocardial infarction and renovascular remodeling in diabetes-mellitus. In this trial participants with mild to severe COPD, with Computed Tomography (CT) evidence of emphysema (5-35% of voxels with < -950 Hounsfield Units), will be randomly assigned to receive 100mg/day of losartan or placebo for 48 weeks. The primary outcome measure will be the rate of progression of emphysema, quantified as the percent of lung voxels with a density less than -950 HU as measured by High Resolution CT (HRCT, from baseline to 48 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Emphysema
Intervention  ICMJE
  • Drug: Losartan
    50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
  • Drug: Placebo
    one capsule per day for two weeks, followed by two capsules per day for 46 weeks
Study Arms  ICMJE
  • Active Comparator: Losartan
    At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
    Intervention: Drug: Losartan
  • Placebo Comparator: placebo
    At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is >90 mm Hg and diastolic BP is > 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2016)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mild to severe COPD: Ratio of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) less than or equal to 0.70, FEV1 20-80% of predicted
  • Current or former smoker
  • HRCT scan with 5-35% of voxels with density less than -950 Hounsfield Units (HU)
  • Ability to understand and willingness to sign consent documents

Exclusion Criteria:

  • Current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB)
  • Known intolerance to ACE inhibitor or ARB
  • History of angioedema
  • Conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy)
  • Renal insufficiency (GFR <30 mL/min by Cockcroft-Gault calculation)
  • Current regular use of NSAIDs defined as daily use 5 or more days of the week for more than one month
  • Potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)/dL or higher at V1
  • Current use of a potassium sparing diuretic
  • COPD exacerbation requiring treatment within 6 weeks at V1
  • Chronic systemic corticosteroid use of more than 10mg/day of prednisone
  • Resting SpO2 <89% on 2 L nasal cannula continuous flow; unless at altitude > 4,000 feet, then resting oxygen saturation (SpO2) <89% on 4 L N C continuous flow
  • Untreated arterial hypertension (systolic blood pressure greater than140 mm Hg, diastolic blood pressure greater than 90 mm Hg)
  • Blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or sitting
  • Known unilateral or bilateral renal artery stenosis higher than 70%
  • Previous lung resection surgery
  • Evidence of interstitial, occupational or chronic infectious lung disease
  • Changes to chest that preclude adequate HRCT imaging (e.g. Metallic objects in the chest such as shrapnel or pacemaker leads)
  • For women of child bearing potential, positive pregnancy test or unwillingness to use two methods of birth control or abstinence for the duration of the study
  • Major chronic illnesses which in the judgment of the study physician would interfere with participation in the study e.g. including but not limited to: cardiac, renal, hepatic (LFTs more than 2.5x normal upper limit), neurological, psychiatric, endocrine or neoplastic diseases, uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, non-skin cancer, rheumatic diseases
  • Failure to keep screening appointments or other indicators of non-adherence
  • Inability to be contacted by telephone
  • Intention to leave area within 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anne Casper, MA 443-287-3170 ashankl1@jhu.edu
Contact: Alexis Rea area5@jhu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02696564
Other Study ID Numbers  ICMJE U01HL128951( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC)
Responsible Party JHSPH Center for Clinical Trials
Study Sponsor  ICMJE JHSPH Center for Clinical Trials
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE
Principal Investigator: Robert Wise, MD Johns Hopkins University
Principal Investigator: Janet Holbrook, PhD Johns Hopkins University Bloomberg School of Public Health
PRS Account JHSPH Center for Clinical Trials
Verification Date July 2018

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