Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a ... View Full Text


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Article Info

DATE

2017-12

AUTHORS

Chin Kook Rhee, Hye Yun Park, Jeong-Woong Park, Ji-Hyun Lee, Tae-Hyung Kim, Sei Won Lee, Ji Ye Jung, Song Kim, Yong Il Hwang, Ki-Suck Jung

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. More... »

PAGES

80

References to SciGraph publications

  • 2010-09-30. Disease severity and symptoms among patients receiving monotherapy for COPD in PRIMARY CARE RESPIRATORY JOURNAL
  • Identifiers

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    http://scigraph.springernature.com/pub.10.1186/s13063-017-1800-3

    DOI

    http://dx.doi.org/10.1186/s13063-017-1800-3

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    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/28228162


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