Long-term safety and efficacy of combined tiotropium and olodaterol in Japanese patients with chronic obstructive pulmonary disease

Masakazu Ichinose, Motokazu Kato, Ayako Takizawa, Wataru Sakamoto, Lars Grönke, Kay Tetzlaff, Yoshinosuke Fukuchi

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)


Background The efficacy and safety of once-daily tiotropium+olodaterol (T+O) (2.5/5 µg or 5/5 µg) for treating chronic obstructive pulmonary disease (COPD) have been demonstrated in the large, multinational, randomized, Phase III studies TONADO® 1 and 2, which included 413 Japanese patients (~80 in each group). This study was conducted to supplement the TONADO® study data to assess long-term safety in ≥100 Japanese patients treated for 1 year in compliance with International Conference on Harmonisation guidelines. Efficacy was evaluated descriptively as a secondary end point. Methods Patients were randomized to 52 weeks of double-blind treatment with once-daily T+O (2.5/5 or 5/5 µg) or O (5 µg) monotherapy via the Respimat® inhaler. We report the safety and efficacy data descriptively. Results The incidence of adverse events (AEs) was comparable in the T+O 2.5/5 µg (75.0%), T+O 5/5 µg (85.4%), and O 5 µg (80.5%) groups, with drug-related AEs being reported in 5.0%, 7.3%, and 4.9% of patients, respectively. Serious AEs were reported in 14 patients (11.5%). The change from baseline in forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h and trough FEV1 were numerically higher in the T+O treatment groups than in the O monotherapy group throughout the study period. Overall safety of T+O was comparable to that in the TONADO® studies. Conclusions No safety concerns for long-term T+O treatment were identified in Japanese patients with COPD. A numerical improvement in lung function was observed with T+O treatment compared to O monotherapy.

Original languageEnglish
Pages (from-to)121-129
Number of pages9
JournalRespiratory Investigation
Issue number2
Publication statusPublished - 2017 Mar 1


  • Chronic obstructive pulmonary disease
  • Japanese patients
  • Olodaterol
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine


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