NCT02696564

Losartan Effects on Emphysema Progression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: JHSPH Center for Clinical Trials · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emphysema

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-05-23
• Primary completion: 2021-03-31
• Completion: 2021-06-30
• First posted: 2016-03-02
• Last updated: 2022-06-01
• Results posted: 2022-06-01

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study