Study in Subjects Greater Than 40 Years of Age With COPD

Summary

This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study. The objectives of this study are: 1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily. 2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.

Timeline

Start

2007-03

Primary completion

2007-10

Completion

2008-04

Outcome

Met primary endpoint

paper At 6 weeks, FEV(1) AUC(0-3) was significantly greater in the formoterol group compared with the placebo group (1.57 vs 1.38 L [p < 0.0001]). PMID 19537837 ↗

Publications

• Results Hanania NA, Boota A, Kerwin E, Tomlinson L, Denis-Mize K. Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: Results from a 6-week, randomized, placebo-controlled, clinical trial. Drugs. 2009 Jun 18;69(9):1205-16. doi: 10.2165/00003495-200969090-00005.

Drugs

Indications