Losartan Effects on Emphysema Progression
LEEP
1 other identifier
interventional
220
1 country
28
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2017
Longer than P75 for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedStudy Start
First participant enrolled
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedResults Posted
Study results publicly available
June 1, 2022
CompletedJune 1, 2022
May 1, 2022
3.9 years
February 25, 2016
March 24, 2022
May 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Mean pct950
change in percentage of voxels with density less than -950 Hounsfield Units
48 weeks
Secondary Outcomes (9)
Change From Baseline in Pre-bronchodilator FEV1 Percent Predicted
48 weeks
Change From Baseline in Post-bronchodilator FEV1 Percent Predicted
48 weeks
Change From Baseline in CAT Score
48 weeks
Change From Baseline in SGRQ Score: Total
48 weeks
Change From Baseline in SGRQ Score: Symptoms
48 weeks
- +4 more secondary outcomes
Study Arms (2)
Losartan
ACTIVE COMPARATORAt 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.
placebo
PLACEBO COMPARATORAt 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JHSPH Center for Clinical Trialslead
- University of Pittsburghcollaborator
Study Sites (28)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
University of Arizona
Tucson, Arizona, 85724, United States
University of California at San Diego
San Diego, California, 92103, United States
University of California at San Francisco
San Francisco, California, 94143, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
Western Connecticut Health Network
Danbury, Connecticut, 06810, United States
University of Florida College of Medicine
Jacksonville, Florida, 32209, United States
University of South Florida
Tampa, Florida, 33613, United States
University of Illinois at Chicago
Chicago, Illinois, 60608, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Hospitals
Chicago, Illinois, 60637, United States
St. Vincent Hospital and Health Care Center, Inc.
Indianapolis, Indiana, 46260, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
University of Michigan
Ann Arbor, Michigan, 48109-5360, United States
St. Louis University School of Medicine
St Louis, Missouri, 63104, United States
St. Louis Asthma Clinical Research Center - Washington University School of Medicine
St Louis, Missouri, 63110, United States
New York University School of Medicine
New York, New York, 10016, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Vermont Lung Center at The University of Vermont
Colchester, Vermont, 05466, United States
Pacific Northwest Airways - VA Puget Sound Healthcare System
Seattle, Washington, 98108, United States
Related Publications (1)
Wise RA, Holbrook JT, Brown RH, Criner GJ, Dransfield MT, He J, Henderson RJ, Kaminsky DA, Kaner RJ, Lazarus SC, Make BJ, McCormack MC, Neptune ER, Que LG. Clinical Trial of Losartan for Pulmonary Emphysema: Pulmonary Trials Cooperative Losartan Effects on Emphysema Progression Clinical Trial. Am J Respir Crit Care Med. 2022 Oct 1;206(7):838-845. doi: 10.1164/rccm.202201-0206OC.
PMID: 35649189DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert A. Wise, M.D.
- Organization
- School of Medicine, Johns Hopkins University
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Wise, MD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Janet Holbrook, PhD
Johns Hopkins University Bloomberg School of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2016
First Posted
March 2, 2016
Study Start
May 23, 2017
Primary Completion
March 31, 2021
Study Completion
June 30, 2021
Last Updated
June 1, 2022
Results First Posted
June 1, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC)