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https://www.readbyqxmd.com/read/27886854/efficacy-and-safety-of-indacaterol-glycopyrronium-in-japanese-patients-with-copd-pooled-analysis-of-shine-and-arise
#1
Kazuhisa Asai, Kazuto Hirata, Shu Hashimoto, Yoshinosuke Fukuchi, Tetsuji Kitawaki, Kimitoshi Ikeda, Robert Fogel, Donald Banerji
BACKGROUND: To better evaluate the efficacy and safety of the indacaterol/glycopyrronium (IND/GLY) fixed-dose combination versus tiotropium in Japanese patients, a pooled data analysis was conducted from the SHINE and ARISE studies, which were part of the IND/GLY clinical trial program. METHODS: Japanese patients with moderate-to-severe COPD were included in the analysis. Efficacy in terms of pre-dose forced expiratory volume in one second (FEV1) at Week 12 and Week 24/26 (ARISE/SHINE) and FEV1 at 30min and 60min post-dose at Day 1, Week 12, and Week 24/26 was evaluated...
November 2016: Respiratory Investigation
https://www.readbyqxmd.com/read/27853383/uk-specific-cost-effectiveness-of-tiotropium-olodaterol-fixed-dose-combination-versus-other-lama-laba-combinations-in-patients-with-copd
#2
Abigail Tebboth, Andrew Ternouth, Nuria Gonzalez-Rojas
OBJECTIVE: The aim of this study is to assess the cost-effectiveness of other long-acting muscarinic antagonist + long-acting β2 agonist combinations in comparison with Spiolto(®) Respimat(®) (tiotropium + olodaterol fixed-dose combination [FDC]) for maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. METHODS: A previously published individual-level Markov model was adapted for the perspective of the UK health care system, in line with recommendations from the National Institute for Health and Care Excellence...
2016: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/27832943/evaluation-of-the-anti-inflammatory-effects-of-%C3%AE-adrenoceptor-agonists-on-human-lung-macrophages
#3
Sharonjit K Gill, Helen M Marriott, S Kim Suvarna, Peter T Peachell
The principal mechanism by which bronchodilator β-adrenoceptor agonists act is to relax airways smooth muscle although they may also be anti-inflammatory. However, the extent of anti-inflammatory activity and the cell types affected by these agonists are uncertain. The purpose of this study was to evaluate whether β-adrenoceptor agonists prevent pro-inflammatory cytokine generation from activated human lung macrophages. Macrophages were isolated and purified from human lung. The cells were pre-treated with both short-acting (isoprenaline, salbutamol, terbutaline) and long-acting (formoterol, salmeterol, indacaterol) β-agonists before activation with lipopolysaccharide (LPS) to induce cytokine (TNFα, IL-6, IL-8 and IL-10) generation...
November 7, 2016: European Journal of Pharmacology
https://www.readbyqxmd.com/read/27812637/effects-of-indacaterol-versus-tiotropium-on-exercise-tolerance-in-patients-with-moderate-copd-a-pilot-randomized-crossover-study
#4
Danilo Cortozi Berton, Álvaro Huber Dos Santos, Ivo Bohn, Rodrigo Quevedo de Lima, Vanderléia Breda, Paulo José Zimermann Teixeira
Objective: To compare a once-daily long-acting β2 agonist (indacaterol 150 µg) with a once-daily long-acting anticholinergic (tiotropium 5 µg) in terms of their effects on exercise endurance (limit of tolerance, Tlim) in patients with moderate COPD. Secondary endpoints were their effects on lung hyperinflation, exercise-related dyspnea, and daily-life dyspnea. Methods: This was a randomized, single-blind, crossover pilot study involving 20 patients (mean age, 60...
September 2016: Jornal Brasileiro de Pneumologia: Publicaça̋o Oficial da Sociedade Brasileira de Pneumologia e Tisilogia
https://www.readbyqxmd.com/read/27785010/efficacy-and-safety-of-indacaterol-glycopyrronium-in-japanese-patients-with-copd-a-subgroup-analysis-from-the-shine-study
#5
Shu Hashimoto, Hisataro Ikeuchi, Shujiro Murata, Tetsuji Kitawaki, Kimitoshi Ikeda, Donald Banerji
BACKGROUND: COPD-related deaths are increasing in Japan, with ~5.3 million people at risk. METHODS: The SHINE was a 26-week, multicenter, randomized, double-blind, parallel-group study that evaluated safety and efficacy of indacaterol (IND)/glycopyrronium (GLY) 110/50 μg once daily (od) compared with GLY 50 μg od, IND 150 μg od, open-label tiotropium (TIO) 18 μg od, and placebo. The primary end point was trough forced expiratory volume in 1 second (FEV1) at Week 26...
2016: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/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
#6
Nanshan Zhong, Changzheng Wang, Xiangdong Zhou, Nuofu Zhang, Michael Humphries, Linda Wang, Francesco Patalano, Donald Banerji
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...
December 2016: COPD
https://www.readbyqxmd.com/read/27692151/computed-tomography-ct-assessed-bronchodilation-induced-by-inhaled-indacaterol-and-glycopyrronium-indacaterol-in-copd
#7
Kaoruko Shimizu, Ruriko Seto, Hironi Makita, Masaru Suzuki, Satoshi Konno, Yoichi M Ito, Rie Kanda, Emiko Ogawa, Yasutaka Nakano, Masaharu Nishimura
BACKGROUND: Our previous studies suggested that the site of bronchodilation on CT might differ between inhaled β2 agonists and inhaled anticholinergics in COPD. AIM: To assess and compare the bronchodilation effects of inhaled indacaterol and glycopyrronium/indacaterol by airway generation in large airways using CT. METHODS: CT scans at full inspiration and pulmonary function tests were done in 25 patients with moderate-severe COPD before and 4-5 weeks after daily inhalation of indacaterol and again another 4-5 weeks after inhalation of glycopyrronium/indacaterol...
October 2016: Respiratory Medicine
https://www.readbyqxmd.com/read/27671235/lung-retention-by-lysosomal-trapping-of-inhaled-drugs-can-be-predicted-in%C3%A2-vitro-with-lung-slices
#8
Erica Bäckström, Elin Boger, Anders Lundqvist, Margareta Hammarlund-Udenaes, Markus Fridén
Modulating and optimizing the local pharmacokinetics of inhaled drugs by chemical design or formulation is challenged by the lack of predictive in vitro systems and in vivo techniques providing a detailed description of drug location in the lung. The present study investigated whether a new experimental setup of freshly prepared agarose-filled lung slices can be used to estimate lung retention in vitro, by comparing with in vivo lung retention after intratracheal instillation. Slices preloaded with inhaled β-adrenergic compounds (salbutamol, formoterol, salmeterol, indacaterol or AZD3199) were incubated in a large volume of buffer (w/wo monensin to assess the role of lysosomal trapping), and the amount remaining in slices at different time points was determined with liquid chromatography-tandem mass spectrometry...
November 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27579650/indacaterol-glycopyrronium-for-copd
#9
LETTER
Frits M E Franssen, Emiel F M Wouters, Lowie E G W Vanfleteren
No abstract text is available yet for this article.
September 1, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27579649/indacaterol-glycopyrronium-for-copd
#10
LETTER
Marco Contoli, Paolo Morelli, Alberto Papi
No abstract text is available yet for this article.
September 1, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27579648/indacaterol-glycopyrronium-for-copd
#11
LETTER
Samy Suissa
No abstract text is available yet for this article.
September 1, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27579647/indacaterol-glycopyrronium-for-copd
#12
LETTER
Jadwiga A Wedzicha, Donald Banerji, Claus F Vogelmeier
No abstract text is available yet for this article.
September 1, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27516088/cost-effectiveness-of-the-long-acting-%C3%AE-2-adrenergic-agonist-laba-long-acting-muscarinic-antagonist-dual-bronchodilator-indacaterol-glycopyrronium-versus-the-laba-inhaled-corticosteroid-combination-salmeterol-fluticasone-in-patients-with-chronic-obstructive
#13
M Reza Maleki-Yazdi, Mathieu Molimard, Dorothy L Keininger, Jean-Bernard Gruenberger, Joao Carrasco, Claudia Pitotti, Elsa Sauvage, Sara Chehab, David Price
OBJECTIVE: The objective of this study was to assess the cost effectiveness of the dual bronchodilator indacaterol/glycopyrronium (IND/GLY) compared with salmeterol/fluticasone combination (SFC) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) who had a history of one or no exacerbations in the previous year, in Canada, France, Italy, and Portugal. METHODS: A patient-level simulation was developed to compare the costs and outcomes of IND/GLY versus SFC based on data from the LANTERN trial (NCT01709903)...
October 2016: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/27439370/abediterol-a-novel-long-acting-%C3%AE-2-agonist-bronchodilation-safety-tolerability-and-pharmacokinetic-results-from-a-single-dose-dose-ranging-active-comparator-study-in-patients-with-copd
#14
Jutta Beier, Helena Pujol, Beatriz Seoane, Eulalia Jimenez, Carol Astbury, Eric Massana, Sandrine Ruiz, Gonzalo de Miquel
BACKGROUND: Abediterol is a novel, once-daily long-acting β2-agonist in development for the treatment of chronic obstructive pulmonary disease (COPD) and asthma in combination with an anti-inflammatory agent. This Phase IIa, randomised, double-blind, crossover study investigated the bronchodilation, safety, tolerability and pharmacokinetics of abediterol in patients with moderate to severe COPD. METHODS: Seventy patients (aged ≥40 years, Global initiative for chronic Obstructive Lung Disease Stage II/III) were randomised (1:1:1:1:1:1) to single doses of abediterol 0...
2016: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/27354040/olodaterol-for-the-treatment-of-chronic-obstructive-pulmonary-disease
#15
REVIEW
Wijdan H Ramadan, Wissam K Kabbara, Rosa M Abilmona
PURPOSE: Published data on the pharmacology, pharmacokinetics, efficacy, and safety of the once-daily, long-acting β2-agonist (LABA) olodaterol are reviewed. SUMMARY: Olodaterol (Striverdi Respimat, Boehringer Ingelheim), a LABA with high selectivity for β2-adrenergic receptors, is indicated for the treatment of chronic obstructive pulmonary disease (COPD); the recommended dose is 5 μg, to be delivered once daily via the Respimat inhaler. In 48- and 6-week Phase III clinical trials of olodaterol evaluating various lung function and symptomatic outcomes in patients with moderate to very severe COPD, olodaterol use was associated with significant improvements in spirometry outcomes, such as postbronchodilator forced expiratory volume in one second (FEV1), as well as dyspnea severity and quality-of-life measures...
August 1, 2016: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/27310329/lung-delivery-of-indacaterol-and-mometasone-furoate-following-inhalation-of-qmf149-in-healthy-volunteers
#16
Soniya S Vaidya, Sanjeev Khindri, Suzanne Maahs, Surendra Machineni, Hisanori Hara, Axel Juan, Günther Kaiser
This single-dose, 4-period crossover study evaluated the pharmacokinetics (PK) of the β2 -agonist indacaterol maleate and the corticosteroid mometasone furoate (MF) after inhalation of a fixed-dose combination (QMF149, indacaterol maleate/MF, 500/400 μg) via the Twisthaler (TH) device with and without activated charcoal and postdose mouth rinsing in healthy volunteers. The PK of indacaterol maleate 300 μg inhaled via the Breezhaler (BRZ) device was also characterized. Relative bioavailability of indacaterol and MF for inhalation with versus without charcoal, based on AUClast, was 0...
July 2016: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/27301417/effects-of-indacaterol-glycopyrronium-qva149-on-lung-hyperinflation-and-physical-activity-in-patients-with-moderate-to-severe-copd-a-randomised-placebo-controlled-crossover-study-the-move-study
#17
Henrik Watz, Claudia Mailänder, Monika Baier, Anne Kirsten
BACKGROUND: Physical activity limitation is common in chronic obstructive pulmonary disease (COPD), and is associated with worse health status, and increased hospitalisation and mortality. Long-acting bronchodilators, either alone or in combination, have been shown to improve exercise intolerance. However, none of these studies were designed with physical activity as primary outcome. This study assessed the effect of indacaterol/glycopyrronium fixed dose combination (IND/GLY) 110/50 μg once daily (OD) versus placebo on lung hyperinflation (inspiratory capacity [IC]) and physical activity in patients with moderate-to-severe COPD...
2016: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/27296533/pharmacological-characterisation-of-the-interaction-between-glycopyrronium-bromide-and-indacaterol-fumarate-in-human-isolated-bronchi-small-airways-and-bronchial-epithelial-cells
#18
Mario Cazzola, Luigino Calzetta, Ermanno Puxeddu, Josuel Ora, Francesco Facciolo, Paola Rogliani, Maria Gabriella Matera
BACKGROUND: Nowadays, there is a considerable gap in knowledge concerning the mechanism(s) by which long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) interact to induce bronchodilation. This study aimed to characterise the pharmacological interaction between glycopyrronium bromide and indacaterol fumarate and to identify the mechanism(s) leading to the bronchorelaxant effect of this interaction. METHODS: The effects of glycopyrronium plus indacaterol on the contractile tone of medium and small human isolated bronchi were evaluated, and acetylcholine and cAMP concentrations were quantified...
June 13, 2016: Respiratory Research
https://www.readbyqxmd.com/read/27254953/-lama-laba-fixed-dose-combination-for-treatment-of-copd
#19
REVIEW
Ichiro Kuwahira
Several new fixed-dose combination bronchodilators have been launched in the world, and 3 different types are now available in Japan. Assessing their efficacy relative to each other has not been performed yet. In the present manuscript, characteristics of glycopyrronium/indacaterol, umeclidinium/vilanterol and tiotropium/olodaterol were reviewed. In particular, changes in trough and peak forced expiratory volume in 1 second (FEV1), St George's Respiratory Questionnaire (SGRQ) total scores, and transitional dyspnea index (TDI) focal scores were reviewed in these bronchodilators...
May 2016: Nihon Rinsho. Japanese Journal of Clinical Medicine
https://www.readbyqxmd.com/read/27254952/-role-of-bronchodilators-in-therapy-for-copd-mechanisms-of-laba-and-lama-on-airway-smooth-muscle
#20
REVIEW
Hiroaki Kume
Long-acting β2-adrenergic receptor agonists (LABAs) and anticholinergics (LAMAs) are widely used clinically as therpy for COPD. Clinical reports have demonstrated that LABAs (salmeterol, formoterol, indacaterol, olodaterol, vilanterol) and LAMAs (tiotropium, glycopyrronium, umeclidinium, aclidinium) are useful to improving symptoms and lung function, and to reducing exacerbation and hospitarization. LABAs expect salmeterol are strong partial agonists, and LAMAs are non-specific antagonists. Ca2+ dynamics and Ca2+ sensitization contribute to relaxation of airway smooth muscle in these bronchodilators...
May 2016: Nihon Rinsho. Japanese Journal of Clinical Medicine
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