Accession Number:

AD1094834

Title:

Beta Blockers for the Prevention of Acute Exacerbations of COPD

Descriptive Note:

Technical Report,30 Sep 2018,29 Sep 2019

Corporate Author:

University of Alabama at Birmingham Birmingham United States

Personal Author(s):

Report Date:

2019-10-01

Pagination or Media Count:

33.0

Abstract:

We conducted a multicenter, randomized, placebo-controlled trial to definitively assess the impact of metoprolol succinate on the rate and severity of COPD exacerbations. The trial planned to enroll 1028 patients over a 3-year period. Study enrollment was halted early on March 21, 2019 based on DSMC recommendation after review of both the futility analysis and emerging safety concerns. Major activities for this reporting period centered on enrollment at clinical sites through March 21, 2019. Final enrollment was 532 subjects. Since March 21, 2019, major activities focused on notifying study participants and efficiently exiting all active study participants. The database has been locked. Initial analysis showed no difference in the risk of COPD exacerbations between the metoprolol and placebo group. The results showed that participants who took metoprolol had a higher risk of hospitalizations for COPD than those that took placebo. A manuscript was submitted to and accepted for publication by the New England Journal of Medicine.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE