Losartan Effects on Emphysema Progression

Completed · Phase 4 · Has a placebo group

Conditions studied: Emphysema

In brief

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 .

Key facts

Study ID

NCT02696564

Run by

JHSPH Center for Clinical Trials

People needed

220

Starts

2017-05-23

Expected to finish

2021-06-30

Last updated by the study team

2022-06-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• University of California at San Diego — San Diego, California, United States
• University of California at San Francisco — San Francisco, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Western Connecticut Health Network — Danbury, Connecticut, United States
• University of Florida College of Medicine — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Hospitals — Chicago, Illinois, United States
• St. Vincent Hospital and Health Care Center, Inc. — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Louisiana State University — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• St. Louis University School of Medicine — St Louis, Missouri, United States
• St. Louis Asthma Clinical Research Center - Washington University School of Medicine — St Louis, Missouri, United States
• New York University School of Medicine — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• Mount Sinai National Jewish Health Respiratory Institute; Icahn School of Medicine — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Temple University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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