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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.
Trials. 2017 02 22; 18(1):80.T

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.

Authors+Show Affiliations

Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.Division of Pulmonary and Allergy Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.Department of Internal Medicine, Bundang CHA Medical Center, CHA University College of Medicine, Seongnam, South Korea.Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.Novartis Korea Ltd., Seoul, South Korea.Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, 896 Pyeongan-dong, Dongan-gu, 431-070, Anyang-si, Gyeonggi-do, South Korea. hyicyk@gmail.com.Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, 896 Pyeongan-dong, Dongan-gu, 431-070, Anyang-si, Gyeonggi-do, South Korea. pulmoks@hallym.ac.kr.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28228162

Citation

Rhee, Chin Kook, et al. "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." Trials, vol. 18, no. 1, 2017, p. 80.
Rhee CK, Park HY, Park JW, et al. 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. Trials. 2017;18(1):80.
Rhee, C. K., Park, H. Y., Park, J. W., Lee, J. H., Kim, T. H., Lee, S. W., Jung, J. Y., Kim, S., Hwang, Y. I., & Jung, K. S. (2017). 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. Trials, 18(1), 80. https://doi.org/10.1186/s13063-017-1800-3
Rhee CK, et al. 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. Trials. 2017 02 22;18(1):80. PubMed PMID: 28228162.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Rhee,Chin Kook, AU - Park,Hye Yun, AU - Park,Jeong-Woong, AU - Lee,Ji-Hyun, AU - Kim,Tae-Hyung, AU - Lee,Sei Won, AU - Jung,Ji Ye, AU - Kim,Song, AU - Hwang,Yong Il, AU - Jung,Ki-Suck, Y1 - 2017/02/22/ PY - 2016/02/12/received PY - 2017/01/14/accepted PY - 2017/2/24/entrez PY - 2017/2/24/pubmed PY - 2018/2/27/medline KW - Bronchodilator agents KW - Chronic obstructive pulmonary disease KW - Indacaterol/glycopyrronium KW - Korea KW - LABA/LAMA combination KW - Tiotropium SP - 80 EP - 80 JF - Trials JO - Trials VL - 18 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/28228162/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1800-3 DB - PRIME DP - Unbound Medicine ER -