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- Title
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.
- Authors
Lee, Sang‐Do; Xie, Can‐mao; Yunus, Faisal; Itoh, Yohji; Ling, Xia; Yu, Wai‐cho; Kiatboonsri, Sumalee
- Abstract
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 East Asian patients. This study aimed to evaluate the efficacy and tolerability of adding budesonide/formoterol to tiotropium compared with tiotropium alone in East Asian patients with severe/very severe COPD. Methods This 12-week, randomized, parallel-group, multicentre, open-label study was conducted in East Asia. 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 ( FEV1) to the mean of values measured at Weeks 1, 6 and 12. Results Pre-dose FEV1 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 St George's Respiratory Questionnaire. Incidence of adverse events was 26% for both groups. Conclusions In East Asian patients with severe/very severe COPD, adding budesonide/formoterol to tiotropium was associated with significant improvements in FEV1 and HRQoL and lower COPD exacerbation rates. Treatment was generally well tolerated. Clinical trial registration: NCT01397890 at Clinicaltrials.gov
- Subjects
OBSTRUCTIVE lung disease treatment; BUDESONIDE; FORMOTEROL; DISEASE exacerbation; TREATMENT effectiveness; THERAPEUTICS
- Publication
Respirology, 2016, Vol 21, Issue 1, p119
- ISSN
1323-7799
- Publication type
Article
- DOI
10.1111/resp.12646