Efficacy of Losartan in Preventing Progression of COPD

NCT00720226 | Completed Phase 4 Results DMC

• 1 other identifier: 1P50HL084945
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD).

Conditions

COPD; Emphysema; Chronic Bronchitis; Smoking

Keywords

COPD; emphysema; angiotensin receptor blocker

Outcome Measures

Primary Outcomes (1)

• Change in Percent Emphysema on CT Scan

  Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.

  Change between baseline and month 12.

Secondary Outcomes (1)

• Change in FEV1 (L)

  Measured at Baseline and Month 12

Study Arms (2)

Losartan

EXPERIMENTAL

Losartan 100 mg daily

Drug: Losartan

Placebo

PLACEBO COMPARATOR

Placebo 1 pill daily

Drug: Placebo

Interventions

Losartan DRUG

Losartan 100 mg daily

Also known as: Cozaar

Losartan

Placebo DRUG

Placebo pill daily

Also known as: "Sugar pill"

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with COPD who are either active or former smokers

You may not qualify if:

• Clinical requirement or history of intolerance of angiotensin receptor blockers, serious heart, liver, kidney, neurological disease.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic; Smoking

Interventions

Losartan; Sugars

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Behavior

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Carbohydrates

Limitations and Caveats

Study was designed as feasibility study for assessment of variability of outcomes and tolerability of treatment in patients with pre-existing emphysema in association with COPD.

Results Point of Contact

• Title: Robert A. Wise
• Organization: Johns Hopkins University School of Medicine

rwise@jhmi.edu

410 550 0545

Study Officials

• Robert A. Wise, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Pulmonary and Critical Care)

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2016
• Last Updated: April 25, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)