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

• Published in: International journal of chronic obstructive pulmonary disease 2017-01, Vol.12, p.3329-3339
• Main Authors: Bai, Chunxue, Ichinose, Masakazu, Lee, Sang Haak, Lee, Kwan Ho, Jöns, Olaf, Bothner, Ulrich, Zhao, Yihua, Buhl, Roland
• Format: Article
• Language: English
• Subjects: Adrenergic beta-2 Receptor Agonists - adverse effects; Adrenergic beta-2 Receptor Agonists - therapeutic use; adverse effects; Aged; Area Under Curve; Asian People; Benzoxazines - adverse effects; Benzoxazines - therapeutic use; Bronchodilator Agents - adverse effects; Bronchodilator Agents - therapeutic use; Chemotherapy; China - epidemiology; Cholinergic Antagonists - adverse effects; Cholinergic Antagonists - therapeutic use; Chronic obstructive lung disease; Chronic obstructive pulmonary disease; Clinical trials; Complications and side effects; COPD; Dosage and administration; Double-Blind Method; Drug Combinations; Drug dosages; Drug therapy; Dyspnea; Female; Forced Expiratory Volume; Health Status; Humans; Inhalers; Lung - drug effects; Lung - physiopathology; Male; Middle Aged; Olodaterol; Original Research; Patients; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - ethnology; Pulmonary Disease, Chronic Obstructive - physiopathology; pulmonary function; Quality of Life; Recovery of Function; Time Factors; Tiotropium; Tiotropium Bromide - adverse effects; Tiotropium Bromide - therapeutic use; Treatment Outcome; Vital Capacity
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S137719

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. 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 ) area under the curve from 0 to 3 hours (AUC ) response and trough FEV 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. In the East Asian population, 1,152 patients were randomized (5,163 overall). After 24 weeks, FEV AUC and trough FEV responses were greater (