Tuberculosis and Respiratory Diseases

  • 제84권2호
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  • Pages.96-104
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  • 2021
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  • 1738-3536(pISSN)
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  • 2005-6184(eISSN)
대한결핵및호흡기학회 (The Korean Academy of Tuberculosis and Respiratory Diseases)
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Direct Switch from Tiotropium to Indacaterol/Glycopyrronium in Chronic Obstructive Pulmonary Disease Patients in Korea

  • Lee, Sang Haak (Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Rhee, Chin Kook (Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Yoo, Kwangha (Division of Pulmonary, Allergy and Critical Care Medicine, Konkuk University Hospital, Konkuk University School of Medicine) ;
  • Park, Jeong Woong (Division of Pulmonology, Allergy and Critical Care, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine) ;
  • Yong, Suk Joong (Department of Internal Medicine, Yonsei University Wonju College of Medicine) ;
  • Kim, Jusang (Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Lee, Taehoon (Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine) ;
  • Lim, Seong Yong (Division of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine) ;
  • Lee, Ji-Hyun (Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, CHA Bundang Medical Center, CHA University) ;
  • Park, Hye Yun (Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Moon, Minyoung (Novartis Korea Ltd.) ;
  • Jung, Ki-Suck (Division of Pulmonary, Allergy and Critical Care Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine)
  • 투고 : 2020.11.26
  • 심사 : 2020.12.21
  • 발행 : 2021.04.30
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초록

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 ㎍ to indacaterol/glycopyrronium (IND/GLY) 110/50 ㎍ 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 ㎍ 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.

키워드

과제정보

The authors thank investigators from all participating study centers for their contribution to conduct of study. The authors also acknowledge Rajendra Prasad for expert review of this draft. Medical writing support was provided by Vatsal Vithlani and Rahul Lad (professional medical writers from Novartis) under author's guidance. The article was prepared in accordance with the third edition of Good Publication Practice guidelines.

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