The effect of COPD severity and study duration on exacerbation outcome in randomized controlled trials.

ABSTRACT:

Background

When discontinuation in COPD randomized controlled trials (RCTs) is unevenly distributed between treatments (differential dropout), the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in RCTs, in relation to study duration and COPD severity.

Methods

A post hoc analysis of 2,345 patients from three RCTs of 6- and 12-month duration was performed to compare budesonide/formoterol and formoterol in moderate, severe, and very severe COPD. Outcomes were exacerbation rate, time-to-first exacerbation, or discontinuation; patients were stratified by disease severity. Outcomes were studied by censoring data monthly from 1 to 12 months.

Results

In patients treated with bud

SUBMITTER: Eriksson G 

PROVIDER: S-EPMC5440002 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature