Ontology highlight
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.
SUBMITTER: Rhee CK
PROVIDER: S-EPMC5322667 | biostudies-literature | 2017 Feb
REPOSITORIES: biostudies-literature
Rhee Chin Kook CK Park Hye Yun HY Park Jeong-Woong JW Lee Ji-Hyun JH Kim Tae-Hyung TH Lee Sei Won SW Jung Ji Ye JY Kim Song S Hwang Yong Il YI Jung Ki-Suck KS
Trials 20170222 1
<h4>Background</h4>Long-acting bronchodilator monotherapy (long-acting β<sub>2</sub>-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.<h4>Methods</h4>This 12-week, randomized, multicenter, open-label, phase I ...[more]