Safety and Tolerability of Once-Daily Tiotropium Respimat Add-On to at Least ICS: Results From Five Phase III Trials in Adult Patients With Symptomatic Asthma.

SESSION TITLE: Asthma Posters ISESSION TYPE: Original Investigation PosterPRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PMPURPOSE: Tiotropium Respimat®, a once-daily long-acting anticholinergic bronchodilator, has been shown to be an efficacious and well tolerated add-on to at least ICS in adult patients with symptomatic asthma. We present key safety data from five Phase III, randomized, double-blind, parallel-group trials that evaluated the efficacy and safety of once-daily tiotropium Respimat® as add-on to at least ICS versus placebo Respimat® in adult patients with symptomatic asthma.METHODS: 2 × 48-week trials of tiotropium Respimat® 5 µg (PrimoTinA-asthma®: NCT00776984; NCT00772538) in patients on high-dose ICS (≥800 µg budesonide or equivalent) plus LABA; 2 × 24-week trials of tiotropium Respimat® 5 µg and 2.5 µg (MezzoTinA-asthma®: NCT01172808, NCT01172821) in patients on medium-dose ICS (400-800 µg budesonide or equivalent); 1 × 12-week trial of tiotropium Respimat® 5 µg and 2.5 µg (GraziaTinA-asthma®: NCT01316380) in patients on low-dose ICS (200-400 µg budesonide or equivalent).RESULTS: 3476 patients were treated. The incidence of any adverse events was similar across treatment groups within each trial, with the majority being mild or moderate in severity. Adverse events reported by ≥5% of patients were similar across all treatment groups within each trial. Adverse events reported by ≥5% of patients across all treatment groups within each trial included asthma, decreased peak expiratory flow, nasopharyngitis, upper respiratory tract infection, headache, and bronchitis. Overall, a low frequency of serious adverse events was observed: PrimoTinA-asthma® tiotropium Respimat® 5 µg 8.1%, placebo Respimat® 8.8%; MezzoTinA-asthma® tiotropium Respimat® 5 µg 2.1%, tiotropium Respimat® 2.5 µg 2.3%, placebo Respimat® 2.7%; GraziaTinA-asthma® tiotropium Respimat® 5 µg 0.6%, tiotropium Respimat® 2.5 µg 0%, placebo Respimat® 0.6%. No deaths occurred.CONCLUSIONS: Once-daily tiotropium Respimat® add-on to at least ICS is well tolerated and has a safety profile comparable to placebo Respimat® in adult patients with symptomatic asthma.CLINICAL IMPLICATIONS: Once-daily tiotropium Respimat® may provide an alternative add-on therapy to at least ICS in adult patients with symptomatic asthma. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.DISCLOSURE: Mark Vandewalker: Grant monies (from industry related sources): Research grant from Boehringer-Ingelheim Eli Meltzer: Grant monies (from industry related sources): Alcon, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, HRA, Kalypsys, Merck, Novartis, Ono, Proctor & Gamble, Rigel, Shionogi, Sunovion, Teva, Consultant fee, speaker bureau, advisory committee, etc.: Alcon, Alexza, AstraZeneca, Bausch + Lomb, Boehringer Ingelheim, Johnson & Johnson, Kalypsys, Meda, Merck, Mylan, Proctor & Gamble, Rigel, Sanofi, Sunovion, Teva Michael Engel: Employee: Boehringer-Ingelheim Ralf Sigmund: Employee: Boehringer-Ingelheim Petra Moroni-Zentgraf: Employee: Boehringer-Ingelheim Huib Kerstjens: Consultant fee, speaker bureau, advisory committee, etc.: From Boerhringer an d Pfizer, in relation to the work presented. As consultant, advisory baord member, and as principal investigator and recruiter., Consultant fee, speaker bureau, advisory committee, etc.: From Almirall, to my institution for consultancies, Consultant fee, speaker bureau, advisory committee, etc.: From Novartis, to my institution for consultanciesThis abstract includes data from clinical trials of tiotropium in asthma. However, tiotropium is not approved for use in asthma and its safety and efficacy have not yet been established in asthma.