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Recruiting Patients After Hospital Discharge for Acute Exacerbation of COPD: Challenges and Lessons Learned.


ABSTRACT: Background: Hospitalizations for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with increased mortality and decreased quality of life. Replicate hospital discharge studies were initiated to examine efficacy and safety of once-daily tiotropium HandiHaler® versus placebo, in addition to usual care, in patients discharged from the hospital after an AECOPD. Methods: Both studies were randomized, placebo-controlled, double-blind, parallel-group, multicenter, with inclusion/exclusion criteria providing a diverse COPD patient cohort hospitalized for ≤14 days with AECOPD. Patients received tiotropium or placebo, initiated within 10 days post-discharge. Target recruitment was 604 patients/study and planned duration was event-driven, en

SUBMITTER: Ferguson GT 

PROVIDER: S-EPMC5764840 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature