Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trialopen access
- Authors
- Rhee, Chin Kook; Park, Hye Yun; Park, Jeong-Woong; Lee, Ji-Hyun; Kim, Tae-Hyung; Lee, Sei Won; Jung, Ji Ye; Kim, Song; Hwang, Yong Il; Jung, Ki-Suck
- Issue Date
- Feb-2017
- Publisher
- BIOMED CENTRAL LTD
- Keywords
- Chronic obstructive pulmonary disease; LABA/LAMA combination; Bronchodilator agents; Korea; Indacaterol/glycopyrronium; Tiotropium
- Citation
- TRIALS, v.18
- Indexed
- SCIE
SCOPUS
- Journal Title
- TRIALS
- Volume
- 18
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/4299
- DOI
- 10.1186/s13063-017-1800-3
- ISSN
- 1745-6215
- Abstract
- Background
Long-acting bronchodilator monotherapy (long-acting β2-agonist [LABA] or long-acting muscarinic antagonist [LAMA]) is extensively used for treatment of patients with chronic obstructive pulmonary disease (COPD) with mild-to-moderate airflow limitation. However, a substantial number of patients remain symptomatic despite treatment with a single bronchodilator, necessitating a change in therapy.
Methods
This 12-week, randomized, multicenter, open-label, phase IV study aims to show that the once-daily indacaterol/glycopyrronium (IND/GLY) 110/50 μg fixed-dose LABA/LAMA combination results in an improved lung function in symptomatic patients with mild-to-moderate COPD who switch from once-daily tiotropium 18 μg. The study aims to enroll a total of 404 symptomatic patients in Korea with mild-to-moderate COPD who received tiotropium for at least 12 weeks prior to the study initiation. The primary objective of this study is to demonstrate the superiority of IND/GLY over tiotropium in terms of trough forced expiratory volume in 1 second (FEV1) following 12 weeks of treatment. Secondary endpoints include the pre-dose trough FEV1 after 4 weeks of treatment, transition dyspnea index (TDI) total score, COPD assessment test (CAT) total score, and rescue medication use following the 12-week treatment, and safety assessment over the 12-week treatment.
Discussion
This study intends to establish the use of LABA/LAMA combination therapy in symptomatic patients with mild-to-moderate COPD by demonstrating the superiority of IND/GLY over tiotropium monotherapy.
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