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标题：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 trial
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作者：Chin Kook Rhee ; Hye Yun Park ; Jeong-Woong Park 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2017
卷号：18
期号：1
页码：80
DOI：10.1186/s13063-017-1800-3
语种：English
出版社：BioMed Central
摘要：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. Trial registration ClinicalTrials.gov, NCT02566031 . Registered on 10 August 2015.
关键词：Chronic obstructive pulmonary disease ; LABA/LAMA combination ; Bronchodilator agents ; Korea ; Indacaterol/glycopyrronium ; Tiotropium