Respiratory Medicine
Volume 104, Issue 2 , Pages 228-236, February 2010

Tiotropium 5μg via Respimat and 18μg via HandiHaler; efficacy and safety in Japanese COPD patients

  • M. Ichinose

      Affiliations

    • Wakayama Medical University, Wakayama, Japan
    • Corresponding Author InformationCorresponding author at: Third Department of Internal Medicine, Wakayama Medical University, 811-1, Kimiidera, Wakayama 641 8509, Japan. Tel.: +81 73 441 0619; fax: +81 73 447 2201.
    • ,
  • T. Fujimoto

      Affiliations

    • Nippon Boehringer Ingelheim, Japan
    • Tsuyoshi Fujimoto, 2-1-1 Osaki, Shinagawa-ku, Tokyo 141 6017, Japan.
    • ,
  • Y. Fukuchi

      Affiliations

    • Juntendo University School of Medicine, Tokyo, Japan
    • Yoshinosuke Fukuchi, 2-9-8-901 Hongo, Bunkyo-ku, Tokyo 113 0033, Japan.

Received 19 August 2009; accepted 17 November 2009. published online 07 December 2009.

Summary 

Background and objectives

To compare the efficacy and safety of tiotropium inhaled via Respimat® Soft Mist Inhaler, a multidose propellant-free inhaler and HandiHaler®, a single-dose dry powder inhaler, in a phase 2 study of Japanese COPD patients.

Methods

Patients with FEV1≤70% predicted, FEV1/FVC≤70% and a smoking history of >10 pack-years received tiotropium once daily via Respimat® (5μg) and HandiHaler® (18μg) for 4 weeks each in a randomised, double-blind, double-dummy, two-way crossover study. Lung function, adverse events, pharmacokinetics and safety were assessed.

Results

Of 184 patients screened, 134 were evaluable. The trough FEV1 response on Day 29 showed Respimat® to be non-inferior to HandiHaler® (mean treatment difference, 0.008L; 95% CI, −0.009 to +0.024L; p<0.001). Peak and average FEV1 and FVC responses on Day 1 and Day 29 were very similar for the two treatments. Tiotropium plasma levels and excretion kinetics showed a similar profile of systemic exposure for the two formulations of tiotropium. Adverse events were reported by similar numbers of patients on each treatment, i.e. 27.9 and 30.6% in the Respimat® and HandiHaler® groups, respectively.

Conclusions

In Japanese patients with COPD, tiotropium Respimat® 5μg and tiotropium HandiHaler® 18μg showed a similar profile of efficacy, safety and pharmacokinetics.

Keywords: Bronchodilators, COPD, Inhalation devices, Pharmacokinetics, Tiotropium

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PII: S0954-6111(09)00375-8

doi:10.1016/j.rmed.2009.11.011

Respiratory Medicine
Volume 104, Issue 2 , Pages 228-236, February 2010

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