Losartan Effects on Emphysema Progression

• Status: Completed
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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

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• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JHSPH Center for Clinical Trials; Johns Hopkins University
• Collaborator: University of Pittsburgh
• Treatments: Losartan

Criteria

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