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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.
COPD. 2016 12; 13(6):686-692.COPD

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, FEV1 AUC0-4h, peak FEV1 and 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+Show Affiliations

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.b Institute of Respiratory Disease, Xin Qiao Hospital, Third Military Medical University , Chongqing City , Chongqing , China.c Department of Respiratory Medicine , Southwest Hospital, Third Military Medical University , Chongqing City , Chongqing , China.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.d Beijing Novartis Pharma Co. Ltd. , Shanghai , China.d Beijing Novartis Pharma Co. Ltd. , Shanghai , China.e Novartis Pharma AG , Basel , Switzerland.f Novartis Pharmaceuticals Corporation , East Hanover , New Jersey , USA.

Pub Type(s)

Comparative Study
Equivalence Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27715335

Citation

Zhong, Nanshan, et al. "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." COPD, vol. 13, no. 6, 2016, pp. 686-692.
Zhong N, Wang C, Zhou X, et al. 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. COPD. 2016;13(6):686-692.
Zhong, N., Wang, C., Zhou, X., Zhang, N., Humphries, M., Wang, L., Patalano, F., & Banerji, D. (2016). 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. COPD, 13(6), 686-692.
Zhong N, et al. 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. COPD. 2016;13(6):686-692. PubMed PMID: 27715335.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Zhong,Nanshan, AU - Wang,Changzheng, AU - Zhou,Xiangdong, AU - Zhang,Nuofu, AU - Humphries,Michael, AU - Wang,Linda, AU - Patalano,Francesco, AU - Banerji,Donald, Y1 - 2016/08/11/ PY - 2016/10/8/pubmed PY - 2017/12/2/medline PY - 2016/10/8/entrez KW - COPD KW - Chinese KW - IND/GLY KW - exacerbations KW - lung function SP - 686 EP - 692 JF - COPD JO - COPD VL - 13 IS - 6 N2 - 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, FEV1 AUC0-4h, peak FEV1 and 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. SN - 1541-2563 UR - https://www.unboundmedicine.com/medline/citation/27715335/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_ L2 - https://www.tandfonline.com/doi/full/10.1080/15412555.2016.1182970 DB - PRIME DP - Unbound Medicine ER -