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Vol.84 No.2
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Direct Switch from Tiotropium to Indacaterol/Glycopyrronium in Chronic Obstructive Pulmonary Disease Patients in Korea

Tuberculosis & Respiratory Diseases / Tuberculosis & Respiratory Diseases,
2021, v.84 no.2, pp.96-104
https://doi.org/10.4046/trd.2020.0109
Lee Sang Haak (Department of Internal Medicine, Eunpyeong St. Mary’s Hospital)



Yong Suk Joong (Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.)
Kim Ju Sang (Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.)
Lee Taehoon (Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.)

Lee Ji Hyun (CHA University)

Moon Minyoung (Novartis Korea Ltd.)

Lee, S. H. , Yong, S. J. , Kim, J. S. , Lee, T. , Lee, J. H. , Moon, M. , & (2021). Direct Switch from Tiotropium to Indacaterol/Glycopyrronium in Chronic Obstructive Pulmonary Disease Patients in Korea. Tuberculosis & Respiratory Diseases, 84(2), 96-104, https://doi.org/10.4046/trd.2020.0109
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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 tiotropium (TIO) 18 μg to indacaterol/glycopyrronium (IND/GLY) 110/50 μg once daily in COPD patients in Korea. Methods: This was a randomized, open-label, parallel group, 12-week trial in mild-to-moderate COPD patients who received TIO 18 μg once daily 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 <0.7 and smoking history of ≥10 pack-years were included. Eligible patients were randomized in a 1:1 ratio to either IND/GLY or TIO. The primary objective was to demonstrate superiority of IND/GLY over TIO in pre-dose trough FEV1 at week 12. Secondary endpoints included transition dyspnea index (TDI) focal score, COPD assessment test (CAT) total score, and rescue medication use following the 12-week treatment, and safety assessment. Results: Of the 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=0.013). Also, numerical improvements were observed with IND/GLY in the 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 by patients. 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.

keywords
Indacaterol/Glycopyrronium, Lung Function, Long-Acting β2-Agonist, Long-Acting Muscarinic Antagonist, Korea, Tiotropium

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