Composite endpoints in COPD: clinically important deterioration in the UPLIFT trial.

ABSTRACT:

Background

Assessments of lung function, exacerbations and health status are common measures of chronic obstructive pulmonary disease (COPD) progression and treatment response in clinical trials. We hypothesised that a composite endpoint could more holistically assess clinically important deterioration (CID) in a COPD clinical trial setting.

Methods

A composite endpoint was tested in a post hoc analysis of 5652 patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2-4 COPD from the 4-year UPLIFT study. Patients received tiotropium 18 μg or placebo.

Results

The composite endpoint included time to first confirmed decrease in trough forced expiratory volume in 1 s (FEV₁) ≥100 mL, confirmed increase in St. George's Respiratory Questionnair

SUBMITTER: Rabe KF 

PROVIDER: S-EPMC7350568 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature