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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

Title
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
Other Titles
glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial
Author
김태형
Keywords
Chronic obstructive pulmonary disease; LABA/LAMA combination; Bronchodilator agents; Korea; Indacaterol/glycopyrronium; Tiotropium
Issue Date
2017-02
Publisher
BIOMED CENTRAL LTD
Citation
TRIALS, v. 18, Article no. 80
Abstract
Background: Long-acting bronchodilator monotherapy (long-acting beta(2)-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 mu g 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 mu g. 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.
URI
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1800-3http://repository.hanyang.ac.kr/handle/20.500.11754/112898
ISSN
1745-6215
DOI
10.1186/s13063-017-1800-3
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COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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