Once-daily tiotropium Respimat®: safety and tolerability results from five Phase III trials in adults with symptomatic asthma
E Beck, T Casale, NA Hanania, J Haughney, M Vandewalker, E Meltzer, P Paggiaro, M Engel, A Unseld, P Moroni-Zentgraf, H Kerstjens · Pneumologie · 2016 · Heft 02
Bibliografische Angaben
Zusammenfassung
Introduction: Tiotropium Respimat® (tioR) has demonstrated efficacy as add-on to at least ICS in adult patients with symptomatic asthma. We present key safety data from five Phase III, double-blind, placebo-controlled, parallel-group trials of once-daily tioR add-on to at least ICS in adult patients with symptomatic asthma. Methods: Two 48-week trials (PrimoTinA-asthma®: NCT00776984/NCT00772538; n = 912) of tioR 5 µg or placebo Respimat® (pboR) add-on to ICS+LABA (≥800 µg budesonide or equivalent); two 24-week trials (MezzoTinA-asthma®: NCT01172808/NCT01172821; n = 2100) of tioR 5 µg, tioR 2.5 µg or placebo add-…