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

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 (FEV ₁ ) area under the curve from 0 to 3 hours (AUC _0-3 ) response and trough FEV ₁ 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, FEV ₁ AUC _0-3 and trough FEV ₁ 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 FEV ₁ 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.
Competing Interests: Disclosure RB reports grants from Boehringer Ingelheim, Novartis, and Roche, and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Novartis, Roche, GlaxoSmithKline, and Takeda. MI reports personal fees from Nippon Boehringer Ingelheim, AstraZeneca, Novartis Pharma KK, and Kyorin. OJ and UB are employees of Boehringer Ingelheim Pharma GmbH & Co. YZ is an employee of Boehringer Ingelheim Pharmaceuticals, Inc. The authors report no other conflicts of interest in this work.