Once-daily tiotropium Respimat® is well tolerated and efficacious over 52 weeks in Japanese patients with symptomatic asthma receiving inhaled corticosteroids (ICS)± long-acting β…
O Schmidt, K Ohta, M Ichinose, Y Tohda, M Engel, P Moroni-Zentgraf, S Kunimitsu, W Sakamoto, M Adachi · Pneumologie · 2015 · Heft 02
Bibliografische Angaben
Zusammenfassung
Rationale: The present study evaluated long-term safety and efficacy of tiotropium Respimat® (tioR) in Japanese patients with moderate to severe symptomatic asthma, despite ICS ± LABA. Methods: In thisPhase III trial across 54 Japanese centers (NCT01340209), patients were randomized to receive evening tioR 5 µg, 2.5 µg, or placebo (PBO), for 52 weeks. Eligible patients: seven-question Asthma Control Questionnaire mean score ≥1.5; forced expiratory volume in 1 second (FEV1) reversibility ≥12% and ≥200 mL; maintenance treatment with medium-dose ICS ± LABA. Primary endpoint: long-term safety; secondary endpoints in…
