Phase 4 N=220 Randomized Triple-blind Treatment

Losartan Effects on Emphysema Progression

Emphysema

Bottom Line

View on ClinicalTrials.gov: NCT02696564 ↗

Enrolled (actual)

220

Serious AEs

19.6%

Results posted

Jun 2022

Primary outcome: Primary: Change in Mean pct950 — 1.35; 0.66 percentage of voxels — p=0.133

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Losartan (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: JHSPH Center for Clinical Trials
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean pct950	1.35; 0.66	0.133
SECONDARY Change From Baseline in Pre-bronchodilator FEV1 Percent Predicted	-0.99; -0.54	0.762
SECONDARY Change From Baseline in Post-bronchodilator FEV1 Percent Predicted	-2.60; -2.37	0.834
SECONDARY Change From Baseline in CAT Score	-0.18; 0.03	0.783
SECONDARY Change From Baseline in SGRQ Score: Total	-1.31; 1.20	0.053
SECONDARY Change From Baseline in SGRQ Score: Symptoms	-6.19; -1.78	0.016 sig
SECONDARY Change From Baseline in SGRQ Score: Activity	-0.66; 2.45	0.065
SECONDARY Change in SGRQ Score: Impact	-0.25; 1.35	0.293
SECONDARY Change From Baseline in mMRC Dyspnea Scale	0.01; 0.11	0.356
SECONDARY Change From Baseline in PROMIS-20a T-score	0.00; -1.04	0.009 sig

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 .

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02696564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.