Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat in chronic obstructive pulmonary disease in two 1-year studies
R Buhl, R Abrahams, L Bjermer, E Derom, M Fležar, J Hébert, A Veale, L Groenke, A Hamilton, K Tetzlaff, L Korducki, H Huisman, S Waitere-Wijker, L McGarvey · Pneumologie · 2015 · Heft 02
Bibliografische Angaben
Zusammenfassung
Introduction: The fixed-dose combination (FDC) of tiotropium (T), a once-daily long-acting muscarinic antagonist, and olodaterol (O), a once-daily long-acting ß2-agonist, is currently being evaluated in chronic obstructive pulmonary disease (COPD). Two 52-week, Phase III replicate pivotal studies were conducted to assess the efficacy and safety of FDCs of T and O (T+O) delivered via Respimat Soft Mist inhaler in patients (pts) with GOLD Stage 2 – 4 COPD. Pooled safety data from the two studies are presented here. Methods: These were double-blind, randomised, parallel-group studies with 5 arms: O 5 µg, T 2.5 µg,…