Losartan Effects on Emphysema Progression



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:7/13/2018
Start Date:May 23, 2017
End Date:January 31, 2021
Contact:Anne Casper, MA
Email:ashankl1@jhu.edu
Phone:443-287-3170

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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

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.

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
We found this trial at
24
sites
660 South Euclid Avenue
Saint Louis, Missouri 63110
Phone: 314-747-3074
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-9240
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Phone: 713-798-2681
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Phone: 813-631-4024
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-764-7388
University of Michigan The University of Michigan was founded in 1817 as one of the...
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303 East Superior Street
Chicago, Illinois 60611
Phone: 312-926-0975
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Chicago, Illinois 60637
Phone: 773-702-4012
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Phone: 312-996-1365
University of Illinois at Chicago A major research university in the heart of one of...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-5987
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Colchester, Vermont 05446
Phone: 802-847-3627
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Denver, Colorado 80206
Phone: 303-398-1443
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-479-0861
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Indianapolis, Indiana 46260
Phone: 317-338-8030
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Jacksonville, Florida 32209
Phone: 904-244-1106
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630 W 168th St
New York, New York
212-305-2862
Phone: 212-305-0251
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10065
Phone: 646-962-2740
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550 1st Ave
New York, New York 10016
(212) 263-7300
Phone: 212-263-2252
New York University School of Medicine NYU School of Medicine has a proud history that...
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Phone: 215-707-1359
Temple University Temple University is many things to many people. A place to pursue life's...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Phone: 412-605-1904
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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San Diego, California 92093
Phone: 619-471-0817
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San Francisco, California 94143
Phone: 415-476-5418
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Seattle, Washington 98108
Phone: 206-764-2558
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Tucson, Arizona 85721
(520) 621-2211
Phone: 520-626-4200
University of Arizona The University of Arizona is a premier, public research university. Established in...
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