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DOI: https://doi.org/10.4046/trd.2020.0109    [Accepted]
Published online December 22, 2020.
Direct switch from tiotropium to indacaterol/glycopyrronium in COPD patients in Korea
Sang Haak Lee, 1, Chin Kook Rhee, 2, Kwangha Yoo, 3, Jeong Woong Park, 4, Suk Joong Yong, 5, Jusang Kim, 6, Taehoon Lee, 7, Seong Yong Lim, 8, Ji-Hyun Lee, 9, Hye Yun Park, 10, Minyoung Moon, 11, Ki-Suck Jung, 12
1Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
2Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
3KonKuk University School of Medicine, Seoul, South Korea
4Gachon University Gil Medical Center, Incheon, South Korea
5Yonsei University Wonju Severance Christian Hospital, Gangwon-do, South Korea
6Division of Pulmonary & Critical Care Medicine, Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
7Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea
8Division of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
9CHA Bundang Medical Center, South Korea
10Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
11Novartis Korea Ltd., Seoul, South Korea
12Hallym University Sacred Heart Hospital, Gyeonggi-do, South Korea
Correspondence:  Ki-Suck Jung,
Email: pulmoks@hallym.ac.kr
Received: 26 November 2020   • Revised: 18 December 2020   • Accepted: 21 December 2020
Abstract
Background
Many chronic obstructive pulmonary disease (COPD) patients receiving monotherapy continue to experience symptoms, exacerbations and poor quality of life. This study aimed to assess the efficacy and safety of direct switch from once-daily (q.d.) tiotropium (TIO) 18 μg to indacaterol/glycopyrronium (IND/GLY) 110/50 μg q.d. in COPD patients from Korea.
Methods
This was a randomized, open-label, parallel group, 12-week trial in mild-to-moderate COPD patients who received TIO 18 μg q.d. for ≥12 weeks prior to study initiation. Patients aged ≥40 years, with predicted post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥50%, post-bronchodilator FEV1/forced vital capacity (FVC) <0.7 and smoking history of ≥10 pack-years were included. Eligible patients were randomized (1:1) to either IND/GLY or TIO. Primary objective was to demonstrate superiority of IND/GLY over TIO in pre-dose trough FEV1 at Week 12. Secondary endpoints include transition dyspnoea index (TDI) focal score, COPD assessment test (CAT) total score, and rescue medication use following 12-week treatment, among others and safety assessment.
Results
Of 442 patients screened, 379 were randomized and 347 completed the study. IND/GLY demonstrated superiority in pre-dose trough FEV1 versus TIO at Week 12 (least squares mean treatment difference [Δ], 50 mL; P=0.0129). Numerical improvements were also observed with IND/GLY in TDI focal score (Δ,0.31), CAT total score (Δ,–0.81) and rescue medication use (Δ,–0.09 puffs/day). Both treatments were well tolerated.
Conclusion
A direct switch from TIO to IND/GLY provided improvements in lung function and other patient-reported outcomes with an acceptable safety profile in patients with mild-to-moderate airflow limitation.
Key Words: Indacaterol/glycopyrronium, lung function, LABA, LAMA, Korea, tiotropium
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