An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

Summary

The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.

Timeline

Start

2007-09-06

Primary completion

2009-05-05

Completion

2009-05-05

Outcome

Met primary endpoint

paper Trough FEV1 at 24 weeks with all BEA2180 doses (0.044-0.087 L) and tiotropium 5 μg (0.092 L) was significantly higher (p < 0.0001) than placebo PMID 23490224 ↗

paper BEA2180 (200 μg) was noninferior to tiotropium PMID 23490224 ↗

Publications

• Abrahams R, Moroni-Zentgraf P, Ramsdell J, Schmidt H, Joseph E, Karpel J. Safety and efficacy of the once-daily anticholinergic BEA2180 compared with tiotropium in patients with COPD. Respir Med. 2013 Jun;107(6):854-62. doi: 10.1016/j.rmed.2013.02.005. Epub 2013 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BEA 2180 BR	Unknown	50 ug	Inhaled
Subject	BEA 2180 BR	Unknown	100 ug	Inhaled
Subject	BEA 2180 BR	Unknown	200 ug	Inhaled
Subject	Tiotropium	Other / unclassified	5 ug	Inhaled

Indications