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
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Rhee, Chin Kook | - |
dc.contributor.author | Park, Hye Yun | - |
dc.contributor.author | Park, Jeong-Woong | - |
dc.contributor.author | Lee, Ji-Hyun | - |
dc.contributor.author | Kim, Tae-Hyung | - |
dc.contributor.author | Lee, Sei Won | - |
dc.contributor.author | Jung, Ji Ye | - |
dc.contributor.author | Kim, Song | - |
dc.contributor.author | Hwang, Yong Il | - |
dc.contributor.author | Jung, Ki-Suck | - |
dc.date.accessioned | 2021-07-30T05:19:54Z | - |
dc.date.available | 2021-07-30T05:19:54Z | - |
dc.date.created | 2021-05-11 | - |
dc.date.issued | 2017-02 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/4299 | - |
dc.description.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. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | BIOMED CENTRAL LTD | - |
dc.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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Tae-Hyung | - |
dc.identifier.doi | 10.1186/s13063-017-1800-3 | - |
dc.identifier.scopusid | 2-s2.0-85013852987 | - |
dc.identifier.wosid | 000396617500002 | - |
dc.identifier.bibliographicCitation | TRIALS, v.18 | - |
dc.relation.isPartOf | TRIALS | - |
dc.citation.title | TRIALS | - |
dc.citation.volume | 18 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.subject.keywordPlus | OBSTRUCTIVE PULMONARY-DISEASE | - |
dc.subject.keywordPlus | DUAL BRONCHODILATION | - |
dc.subject.keywordPlus | QVA149 | - |
dc.subject.keywordPlus | GOLD | - |
dc.subject.keywordAuthor | Chronic obstructive pulmonary disease | - |
dc.subject.keywordAuthor | LABA/LAMA combination | - |
dc.subject.keywordAuthor | Bronchodilator agents | - |
dc.subject.keywordAuthor | Korea | - |
dc.subject.keywordAuthor | Indacaterol/glycopyrronium | - |
dc.subject.keywordAuthor | Tiotropium | - |
dc.identifier.url | https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1800-3 | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
222, Wangsimni-ro, Seongdong-gu, Seoul, 04763, Korea+82-2-2220-1365
COPYRIGHT © 2021 HANYANG UNIVERSITY.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.