Efficacy and Safety of Roflumilast in Korean Patients with COPD.

ABSTRACT:

Purpose

Roflumilast is the only oral phosphodiesterase 4 inhibitor approved to treat chronic obstructive pulmonary disease (COPD) patients [post-bronchodilator forced expiratory volume in 1 second (FEV₁) <50% predicted] with chronic bronchitis and a history of frequent exacerbations. This study evaluated the efficacy and safety of roflumilast in Korean patients with COPD and compared the efficacy based on the severity of airflow limitation.

Materials and methods

A post-hoc subgroup analysis was performed in Korean COPD patients participating in JADE, a 12-week, double-blinded, placebo-controlled, parallel-group, phase III trial in Asia. The primary efficacy endpoint was the mean [least-squares mean adjusted for covariates (LSMean)] change in post-bronchodilator FEV₁ from bas

SUBMITTER: Lee JS 

PROVIDER: S-EPMC4951470 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature