Introduction The fixed-dose combination (FDC) of tiotropium (T), a once-daily long-acting muscarinic antagonist, and olodaterol (O), a once-daily long-acting β₂-agonist, is currently being evaluated in chronic obstructive pulmonary disease (COPD).

Two 52-week, Phase III replicate pivotal studies were conducted to assess the efficacy and safety of FDCs of T and O (T+O) delivered via Respimat® Soft Mist™ inhaler in patients (pts) with GOLD Stage 2–4 COPD. Pooled safety data from the two studies are presented here.

Methods These were double-blind, randomised, parallel-group studies with 5 arms: O 5 µg, T 2.5 µg, T 5 µg, T+O 2.5/5 µg, T+O 5/5 µg. Key inclusion criteria were: age ≥40 years, diagnosis of COPD, smoking history >10 pack-years. Pts with a history of asthma or significant disease other than COPD were excluded. Adverse events (AEs) were reported throughout the studies.

Results A total of 5162 pts were randomised and treated. In general, AEs, serious AEs and fatal AEs were balanced across treatment groups. In particular, frequencies of AEs in the cardiac disorders System Organ Class (SOC) and respiratory disorders SOC were similar.

Conclusions T+O FDCs were safe and well tolerated. In comparison to the individual components, there was no notable increase in AEs with T+O FDCs.