Abstract
BackgroundLong-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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT02566031. Registered on 10 August 2015.
Highlights
Long-acting bronchodilator monotherapy is extensively used for treatment of patients with chronic obstructive pulmonary disease (COPD) with mild-to-moderate airflow limitation
This study aims to evaluate the effect of the alternative treatment with a Long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) combination (IND/ GLY 110/50 μg) in Global Strategy for the Diagnosis (GOLD) group B (FEV1 ≥ 50% of the predicted normal value and COPD assessment test (CAT) ≥10) patients who remain symptomatic despite maintenance treatment with a LAMA
This study aims to provide evidence in addition to the existing data to demonstrate the superiority of once-daily IND/GLY 110/50 μg over once-daily tiotropium18 μg in improving lung function over once-daily tiotropium18 μg in symptomatic patients with mild-to-moderate COPD
Summary
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. Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by persistent airflow limitation. Among Korean adults aged ≥40 years, COPD prevalence in 2008, determined using spirometry was 13.4% [3]. Patients with COPD, with mild-to-moderate airflow limitation (trough forced expiratory volume in 1 second [FEV1] ≥ 50% of the predicted value), with
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