Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease

Chunxue Bai, Masakazu Ichinose, Sang Haak Lee, Kwan Ho Lee, Olaf Jöns, Ulrich Bothner, Yihua Zhao, Roland Buhl

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)

Abstract

Background and purpose: While the efficacy and safety of combined tiotropium and olodaterol in patients with COPD was established in a large clinical trial program, it is important to assess whether clinical data can be applied to geographic patient groups, particularly for East Asian patients who may have a different phenotypic profile to the global trial population. This study aimed to compare the lung function and safety profiles of tiotropium/olodaterol and monocomponents in East Asian and global populations from the TONADO® trials. Materials and methods: In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase III TONADO studies, patients received tiotropium/olodaterol, tiotropium, or olodaterol. We assessed the forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours (AUC0-3) response and trough FEV1 response at 24 weeks for the approved doses, tiotropium/olodaterol 5/5 µg, tiotropium 5 µg, and olodaterol 5 µg. Treatment-emergent adverse events were recorded throughout treatment and ≤21 days after study medication. Results: In the East Asian population, 1,152 patients were randomized (5,163 overall). After 24 weeks, FEV1 AUC0-3 and trough FEV1 responses were greater (P<0.0001) with tiotropium/olodaterol 5/5 µg in both populations versus tiotropium or olodaterol. The East Asian population showed slightly greater trough FEV1 treatment differences between tiotropium/olodaterol 5/5 µg and tiotropium compared to the overall population. Generally, no increase in adverse events was seen with tiotropium/olodaterol 5/5 µg compared to tiotropium and olodaterol in either population. Conclusion: The efficacy and safety profile of tiotropium/olodaterol 5/5 µg has been demonstrated for both East Asian and global populations.

Original languageEnglish
Pages (from-to)3329-3339
Number of pages11
JournalInternational Journal of COPD
Volume12
DOIs
Publication statusPublished - 2017 Nov 20

Keywords

  • Adverse effects
  • COPD
  • Pulmonary function
  • TONADO®

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Health Policy
  • Public Health, Environmental and Occupational Health

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