Efficacy and tolerability of budesonide/formoterol added to tiotropium compared with tiotropium alone in patients with severe or very severe COPD : A randomized, multicentre study in East Asia

Background and objective Triple combination therapy with tiotropium plus budesonide/formoterol has improved lung function and reduced exacerbation risk in patients with chronic obstructive pulmonary disease ( COPD ) in Western countries, but no such data exist for E ast A sian patients. This study aimed to evaluate the efficacy and tolerability of adding budesonide/formoterol to tiotropium compared with tiotropium alone in E ast A sian patients with severe/very severe COPD . Methods This 12‐week, randomized, parallel‐group, multicentre, open‐label study was conducted in E ast A sia. After a 14‐day run‐in period during which patients received tiotropium 18 μg once daily, patients were randomized to tiotropium (18 μg once daily) + budesonide/formoterol (160/4.5 μg 2 inhalations twice daily) or tiotropium alone (18 μg once daily). The primary endpoint was change from baseline in pre‐dose forced expiratory volume in 1 s ( FEV 1 ) to the mean of values measured at Weeks 1, 6 and 12. Results Pre‐dose FEV 1 significantly increased from baseline with tiotropium plus budesonide/formoterol ( n  = 287) versus tiotropium alone ( n  = 291) (5.0% vs 0.6%; treatment difference: 4.4% (95% CI : 1.9–6.9), P  = 0.0004). Triple therapy also reduced the COPD exacerbation rate by 40.7% ( P  = 0.0032) and prolonged time to first exacerbation (38.6% risk reduction, P  = 0.0167) versus tiotropium alone and markedly improved health‐related quality of life ( HRQoL ), measured using the S t G eorge's R espiratory Q uestionnaire. Incidence of adverse events was 26% for both groups. Conclusions In E ast A sian patients with severe/very severe COPD , adding budesonide/formoterol to tiotropium was associated with significant improvements in FEV 1 and HRQoL and lower COPD exacerbation rates. Treatment was generally well tolerated. Clinical trial registration: NCT01397890 at Clinicaltrials.gov