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Tara Rheault, Sanjeev Khindri, Mitra Vahdati-Bolouri, Alison Church, William A Fahy
This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease. This was a 12-week, multicentre, randomised, open-label, parallel-group study ( NCT02236611). Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at day 85 in the per-protocol population...
April 2016: ERJ Open Research
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...
August 11, 2016: COPD
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
Dave Singh, Alberto Papi, Massimo Corradi, Ilona Pavlišová, Isabella Montagna, Catherine Francisco, Géraldine Cohuet, Stefano Vezzoli, Mario Scuri, Jørgen Vestbo
BACKGROUND: Few data are available for the efficacy of "triple therapy" with two long-acting bronchodilators and an inhaled corticosteroid in chronic obstructive pulmonary disease (COPD). We designed this study to assess efficacy of single-inhaler combination of an extra fine formulation of beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) in COPD compared with beclometasone dipropionate and formoterol fumarate (BDP/FF) treatment. METHODS: TRILOGY was a randomised, parallel group, double-blind, active-controlled study done in 159 sites across 14 countries...
September 3, 2016: Lancet
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
Marco Contoli, Paolo Morelli, Alberto Papi
No abstract text is available yet for this article.
September 1, 2016: New England Journal of Medicine
Samy Suissa
No abstract text is available yet for this article.
September 1, 2016: New England Journal of Medicine
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
Christianne M Blais, Beth E Davis, Donald W Cockcroft
UNLABELLED: The duration of bronchoprotection against methacholine-induced bronchoconstriction by long-acting muscarinic antagonists (LAMA's) in asthmatics and whether these drugs differ in their pharmacodynamic properties remain to be determined. The most recent published guidelines for methacholine challenge testing (MCT) suggest that LAMA's should be abstained from for 48 h prior to testing, perhaps one week in the case of tiotropium. The objectives were to determine and compare the duration of protection of a single dose of two different LAMA's, tiotropium and glycopyrronium, against methacholine-induced bronchoconstriction...
September 2016: Respiratory Medicine
Dejan Radovanovic, Marco Mantero, Giuseppe Francesco Sferrazza Papa, Vincenzo Valenti, Stefano Aliberti, Fabiano Di Marco, Pierachille Santus
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is characterized by a high disability and increasing mortality. Bronchodilators are the cornerstone of pharmacological treatment in COPD, while therapeutic optimization with an improvement in symptoms and compliance represent the actual goals. This has led to the development of devices that combine different classes of inhalatory drugs. Recently, a novel combination of the long acting antimuscarinic agent glycopyrronium bromide and the beta2-agonist formoterol fumarate has been developed in a metered dose inhaler delivery system...
October 2016: Expert Review of Respiratory Medicine
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
Paolo Montuschi, Mario Malerba, Giuseppe Macis, Nadia Mores, Giuseppe Santini
Combining individual drugs in a single inhaler is the most convenient way to deliver triple therapy. A long-acting muscarinic receptor antagonist (LAMA) added to an inhaled corticosteroid (ICS)/long-acting β2-adrenoceptor agonist (LABA) fixed-dose combination (FDC) can improve efficacy of pharmacological treatment of patients with chronic obstructive pulmonary disease (COPD). New inhaled ICS/LABA/LAMA FDCs, including fluticasone furoate/vilanterol/umeclidinium, budesonide/formoterol/glycopyrronium and beclometasone/formoterol/glycopyrronium, are in Phase III of clinical development for COPD...
July 21, 2016: Drug Discovery Today
Jose M Marin, Kai M Beeh, Andreas Clemens, Walter Castellani, Lennart Schaper, Dinesh Saralaya, Anthony Gunstone, Ricard Casamor, Konstantinos Kostikas, Maryam Aalamian-Mattheis
BACKGROUND: Morning symptoms associated with COPD have a negative impact on patients' quality of life. Long-acting bronchodilators with rapid onset may relieve patients' symptoms. In the Symptoms and Pulmonary function in the moRnING study, we prospectively compared the rapid onset bronchodilator profile of glycopyrronium (GLY) and tiotropium (TIO) during the first few hours after dosing in patients with moderate-to-severe COPD. METHODS: Patients were randomized (1:1) to receive either once-daily GLY (50 μg) or TIO (18 μg) and corresponding placebos in a cross-over design for 28 days...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Oskar Eklund, Faraz Afzal, Fredrik Borgström, Jason Flavin, Andrew Ternouth, Maria Eugenia Ojanguren, Carlos Crespo, Mike Baldwin
OBJECTIVES: Tiotropium (TIO), Spiriva® Handihaler®, is a well-established bronchodilator, LAMA (long acting muscarinic antagonist), for the treatment of moderate to very severe chronic obstructive pulmonary disease (COPD). Clinical evidence from the SPARK trial suggests that TIO is superior to glycopyrronium (GLY), Seebri® Breezhaler®, in terms of severe exacerbations. This modeling study assessed the cost-effectiveness of TIO versus GLY for Canada (CAN), Spain (ESP), Sweden (SWE), and the UK, making use of this new clinical evidence...
2016: ClinicoEconomics and Outcomes Research: CEOR
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
Michael H Chiu, Nawaf S Al-Majed, Ryan Stubbins, Dylan Pollmann, Roopinder K Sandhu
BACKGROUND: Glycopyrronium bromide has recently been approved as a once daily maintenance inhalation therapy for moderate to severe chronic obstructive pulmonary disease (COPD). Efficacy and safety trial data have found rare cases of significant QT prolongation. To our knowledge, we describe the first case report of QT prolongation >600 ms with initiation of glycopyrronium bromide in a real world setting. CASE PRESENTATION: A 78-year-old female with moderate COPD recently started on glycopyrronium bromide, presented to Emergency Department (ED) with syncope...
2016: BMC Research Notes
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
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
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
Fabrizia Mariotti, Giorgia Ciurlia, Luca Spaccapelo, Annamaria Muraro, Daniela Acerbi
BACKGROUND AND OBJECTIVES: CHF 5993 is an extrafine 'triple therapy' combination of the long-acting muscarinic antagonist glycopyrronium bromide (GB), the long-acting β2-agonist formoterol fumarate (FF), and the inhaled corticosteroid beclometasone dipropionate (BDP). It is in development for chronic obstructive pulmonary disease and asthma delivered via pressurised metered-dose inhaler. METHODS: This two-period, open-label, crossover study examined the drug-drug interaction of CHF 5993 and cimetidine...
May 21, 2016: European Journal of Drug Metabolism and Pharmacokinetics
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