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Beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease

NCT02587351 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2021-01-25

Study results available
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Summary

This is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that will enroll 1028 patients with at least moderately severe COPD over a three year period and follow them at regular intervals for one year. The primary endpoint is time to first acute exacerbation. Secondary endpoints include rates and severity of COPD exacerbations, cardiovascular events, all-cause mortality, lung function, dyspnea, quality of life and metoprolol-related side effects.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Metoprolol succinate

Extended release Metoprolol succinate

OTHER

Placebo

Matching placebo

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Mark Dransfield, MD · University of Alabama at Birmingham

  • John Connett, PhD · University of Minnesota

  • Stephen Lazarus, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2019-09-01
Completion
2019-12-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02587351 on ClinicalTrials.gov