BACKGROUND: Chronic obstructive pulmonary disease (COPD) is one of the major causes of morbidity and mortality worldwide and in China . For patients with more severe symptoms, initial treatment with long acting ß2-agonists and long-acting muscarinic antagonists combination therapy is recommended . Tiotropium + olodaterol fixed-dose combination (Tio+Olo FDC) is an aqueous solution of tiotropium bromide and olodaterol delivered by the RESPIMAT® Soft MistTM inhaler for patients with moderate to very severe COPD .
METHODS: This single site, open-label, phase Ib clinical study assessed the pharmacokinetic (PK) and safety profiles of once-daily Tio+Olo FDC (5 µg/5 µg) after single dose and at steady state in Chinese patients with moderate to severe COPD over 3 weeks . The PK and safety profiles of Japanese and Caucasian populations from 2 independent COPD studies were provided for comparison .
RESULTS: A total of 12 Chinese patients received Tio+Olo FDC . After multiple inhaled administration of Tio+Olo FDC, tiotropium and olodaterol were rapidly absorbed and reached peak plasma concentration at about 5 and 25 min, respectively . The accumulation ratios after multiple administrations were 1.3 and 1.6 for tiotropium and olodaterol in Chinese patients . Tio+Olo FDC was well-tolerated; all AEs were mild .
CONCLUSION: Tio+Olo FDC (5 µg/5 µg) was rapidly absorbed and had a good safety profile in Chinese patients with COPD.