title: Efficacy and Safety of Indacaterol/Glycopyrronium (IND/GLY) Versus Salmeterol/Fluticasone in Chinese Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: The Chinese Cohort from the LANTERN Study.
abstract: Inhaled indacaterol/glycopyrronium fixed-dose combination (IND/GLY) is approved in over 80 countries, including the EU, Japan, Australia and Switzerland and the US. The LANTERN study evaluated the efficacy of IND/GLY compared with inhaled long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) or salmeterol/fluticasone (SFC) in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year. Here we present the efficacy and safety of IND/GLY versus SFC in the Chinese cohort from the LANTERN study. LANTERN was a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group study conducted in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year. The patients were randomized (1:1) to once-daily IND/GLY (110/50 μg) or twice-daily SFC (50/500 μg). The primary endpoint was non-inferiority of IND/GLY versus SFC in terms of trough FEV1. Of the total 744 patients randomized in the LANTERN study, 598 (80.4%) were from Mainland China and randomized to IND/GLY (n = 298) or SFC (n = 300), and 553 (92.5%) completed the study. IND/GLY showed superiority over SFC with a statistically significant and clinically meaningful improvement in trough FEV1, FEV1AUC0-4h, peak FEV1and trough forced vital capacity (FVC) change from the baseline. Annualized rate of moderate or severe COPD exacerbations was significantly lower (43%) with IND/GLY compared with SFC (rate ratio: 0.57, p = 0.015). Overall, adverse events were lower for IND/GLY (34.6%) versus SFC (43.1%). IND/GLY was superior in achieving bronchodilation versus SFC in a Chinese subgroup of patients from this study. Clinicaltrials.gov identifier: NCT01709903.
authors.affiliation: a State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University , Guangzhou , Guangdong , China.
authors.forename: Nanshan
authors.initials: N
authors.lastname: Zhong
authors.affiliation: b Institute of Respiratory Disease, Xin Qiao Hospital, Third Military Medical University , Chongqing City , Chongqing , China.
authors.forename: Changzheng
authors.initials: C
authors.lastname: Wang
authors.affiliation: c Department of Respiratory Medicine , Southwest Hospital, Third Military Medical University , Chongqing City , Chongqing , China.
authors.forename: Xiangdong
authors.initials: X
authors.lastname: Zhou
authors.affiliation: a State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University , Guangzhou , Guangdong , China.
authors.forename: Nuofu
authors.initials: N
authors.lastname: Zhang
authors.affiliation: d Beijing Novartis Pharma Co. Ltd. , Shanghai , China.
authors.forename: Michael
authors.initials: M
authors.lastname: Humphries
authors.affiliation: d Beijing Novartis Pharma Co. Ltd. , Shanghai , China.
authors.forename: Linda
authors.initials: L
authors.lastname: Wang
authors.affiliation: e Novartis Pharma AG , Basel , Switzerland.
authors.forename: Francesco
authors.initials: F
authors.lastname: Patalano
authors.affiliation: f Novartis Pharmaceuticals Corporation , East Hanover , New Jersey , USA.
authors.forename: Donald
authors.initials: D
authors.lastname: Banerji
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002681:China; D018450:Disease Progression; D004311:Double-Blind Method; D004338:Drug Combinations; D004417:Dyspnea / Q000209:etiology; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage / Q000627:therapeutic use*; D005541:Forced Expiratory Volume; D006024:Glycopyrrolate / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D014797:Vital Capacity
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D007189:Indans; D018727:Muscarinic Antagonists; D015363:Quinolones; C510790:indacaterol; D006024:Glycopyrrolate
keywords: COPD; Chinese; IND/GLY; exacerbations; lung function