Cited 3 times in
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 |
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dc.contributor.author | 정지예 | - |
dc.date.accessioned | 2023-08-09T02:53:05Z | - |
dc.date.available | 2023-08-09T02:53:05Z | - |
dc.date.issued | 2017-02 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/195905 | - |
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. Trial registration: ClinicalTrials.gov, NCT02566031 . Registered on 10 August 2015. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | BioMed Central | - |
dc.relation.isPartOf | TRIALS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Administration, Inhalation | - |
dc.subject.MESH | Adrenergic beta-2 Receptor Agonists / administration & dosage* | - |
dc.subject.MESH | Adrenergic beta-2 Receptor Agonists / adverse effects | - |
dc.subject.MESH | Bronchodilator Agents / administration & dosage* | - |
dc.subject.MESH | Bronchodilator Agents / adverse effects | - |
dc.subject.MESH | Cholinergic Antagonists / administration & dosage* | - |
dc.subject.MESH | Cholinergic Antagonists / adverse effects | - |
dc.subject.MESH | Clinical Protocols | - |
dc.subject.MESH | Drug Administration Schedule | - |
dc.subject.MESH | Drug Combinations | - |
dc.subject.MESH | Drug Substitution* | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Forced Expiratory Volume | - |
dc.subject.MESH | Glycopyrrolate / administration & dosage* | - |
dc.subject.MESH | Glycopyrrolate / adverse effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Indans / administration & dosage* | - |
dc.subject.MESH | Indans / adverse effects | - |
dc.subject.MESH | Lung / drug effects* | - |
dc.subject.MESH | Lung / physiopathology | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Pulmonary Disease, Chronic Obstructive / diagnosis | - |
dc.subject.MESH | Pulmonary Disease, Chronic Obstructive / drug therapy* | - |
dc.subject.MESH | Pulmonary Disease, Chronic Obstructive / physiopathology | - |
dc.subject.MESH | Quinolones / administration & dosage* | - |
dc.subject.MESH | Quinolones / adverse effects | - |
dc.subject.MESH | Recovery of Function | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Research Design | - |
dc.subject.MESH | Severity of Illness Index | - |
dc.subject.MESH | Spirometry | - |
dc.subject.MESH | Time Factors | - |
dc.subject.MESH | Tiotropium Bromide / administration & dosage* | - |
dc.subject.MESH | Tiotropium Bromide / adverse effects | - |
dc.subject.MESH | Treatment Outcome | - |
dc.subject.MESH | Vital Capacity | - |
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.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Chin Kook Rhee | - |
dc.contributor.googleauthor | Hye Yun Park | - |
dc.contributor.googleauthor | Jeong-Woong Park | - |
dc.contributor.googleauthor | Ji-Hyun Lee | - |
dc.contributor.googleauthor | Tae-Hyung Kim | - |
dc.contributor.googleauthor | Sei Won Lee | - |
dc.contributor.googleauthor | Ji Ye Jung | - |
dc.contributor.googleauthor | Song Kim | - |
dc.contributor.googleauthor | Yong Il Hwang | - |
dc.contributor.googleauthor | Ki-Suck Jung | - |
dc.identifier.doi | 10.1186/s13063-017-1800-3 | - |
dc.contributor.localId | A03735 | - |
dc.relation.journalcode | J02759 | - |
dc.identifier.eissn | 1745-6215 | - |
dc.identifier.pmid | 28228162 | - |
dc.subject.keyword | Bronchodilator agents | - |
dc.subject.keyword | Chronic obstructive pulmonary disease | - |
dc.subject.keyword | Indacaterol/glycopyrronium | - |
dc.subject.keyword | Korea | - |
dc.subject.keyword | LABA/LAMA combination | - |
dc.subject.keyword | Tiotropium | - |
dc.contributor.alternativeName | Jung, Ji Ye | - |
dc.contributor.affiliatedAuthor | 정지예 | - |
dc.citation.volume | 18 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 80 | - |
dc.identifier.bibliographicCitation | TRIALS, Vol.18(1) : 80, 2017-02 | - |
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