A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:

Phase 3 Completed 626 enrolled AstraZeneca

RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.

Timeline

Start: 2011-03
Primary completion: 2012-05
Completion: 2012-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); Roflumilast vs Placebo; p <0.0001; LSM Difference 0.071 (95% CI 0.046 to 0.095); Repeated measures ANCOVA NCT01313494 ↗

paper Roflumilast provided a sustained increase over placebo in mean prebronchodilator FEV1 (0.071 L; 95% CI, 0.046, 0.095 L; P < .0001). PMID 24135893 ↗

Publications

Zheng J, Yang J, Zhou X, Zhao L, Hui F, Wang H, Bai C, Chen P, Li H, Kang J, Brose M, Richard F, Goehring UM, Zhong N. Roflumilast for the treatment of COPD in an Asian population: a randomized, double-blind, parallel-group study. Chest. 2014 Jan;145(1):44-52. doi: 10.1378/chest.13-1252.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roflumilast	Small molecule	500 ug	Oral
Background	Salbutamol	Unknown	—	Inhaled