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Glycopyrronium

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https://www.readbyqxmd.com/read/29779416/long-term-triple-therapy-de-escalation-to-indacaterol-glycopyrronium-in-copd-patients-sunset-a-randomized-double-blind-triple-dummy-clinical-trial
#1
Kenneth R Chapman, John R Hurst, Stefan-Marian Frent, Michael Larbig, Robert Fogel, Tadhg Guerin, Donald Banerji, Francesco Patalano, Pankaj Goyal, Pascal Pfister, Konstantinos Kostikas, Jadwiga A Wedzicha
RATIONALE: There are no studies on ICS withdrawal in patients on long-term triple therapy in the absence of frequent exacerbations. OBJECTIVE: To evaluate the efficacy and safety of the direct de-escalation from long-term triple therapy to indacaterol/glycopyrronium in non-frequently exacerbating COPD patients. METHODS: This 26-week, randomized, double-blind, triple-dummy study assessed the direct change from long-term triple therapy to indacaterol/glycopyrronium (110/50μg once daily) or continuation of triple therapy (tiotropium 18μg once daily plus combination of salmeterol/fluticasone propionate [50/500μg] twice daily) in non-frequently exacerbating patients with moderate-to-severe COPD...
May 20, 2018: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29773969/cost-effectiveness-of-umeclidinium-compared-with-tiotropium-and-glycopyrronium-as-monotherapy-for-chronic-obstructive-pulmonary-disease-a-uk-perspective
#2
Dhvani Shah, Maurice Driessen, Nancy Risebrough, Timothy Baker, Ian Naya, Andrew Briggs, Afisi S Ismaila
Background: Cost-effectiveness of once-daily umeclidinium bromide (UMEC) was compared with once-daily tiotropium (TIO) and once-daily glycopyrronium (GLY) in patients with chronic obstructive pulmonary disease (COPD) from a UK National Health Service (NHS) perspective. Methods: A linked-equation model was implemented to estimate COPD progression, associated healthcare costs, exacerbations rates, life years (LY) and quality-adjusted LY (QALYs). Statistical risk equations for endpoints and resource use were derived from the ECLIPSE and TORCH studies, respectively...
2018: Cost Effectiveness and Resource Allocation: C/E
https://www.readbyqxmd.com/read/29763659/safety-and-pharmacokinetics-of-budesonide-glycopyrronium-formoterol-fumarate-dihydrate-metered-dose-inhaler-bgf-mdi-in-healthy-adult-subjects-of-japanese-descent
#3
Paul Dorinsky, Paolo DePetrillo, Shahid Siddiqui, Andrea Maes, Colin Reisner
INTRODUCTION: BGF MDI, a budesonide, glycopyrronium, and formoterol fumarate dihydrate triple fixed-dose combination metered dose inhaler formulated using co-suspension delivery technology, is currently in Phase III global development for chronic obstructive pulmonary disease. METHODS: This was a Phase I, randomized, double-blind, placebo-controlled, ascending-dose, crossover study to assess the safety and pharmacokinetic profiles of two doses of BGF MDI in healthy adult subjects of Japanese descent (NCT02197975)...
May 12, 2018: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29724397/randomized-study-of-the-effects-of-aerochamber-plus-%C3%A2-flow-vu-%C3%A2-on-the-efficacy-pharmacokinetics-and-safety-of-glycopyrronium-formoterol-fumarate-dihydrate-metered-dose-inhaler-in-patients-with-chronic-obstructive-pulmonary-disease
#4
Faisal Fakih, Selwyn Spangenthal, Barry Sigal, Patrick Darken, Andrea Maes, Shahid Siddiqui, Michael Gillen, Colin Reisner, Ubaldo J Martin
OBJECTIVES: This study compared the efficacy, pharmacokinetics (PK), and safety of GFF MDI (Bevespi Aerosphere® ), a fixed-dose combination of glycopyrronium and formoterol fumarate dihydrate (14.4/10 μg) delivered by a metered dose inhaler (MDI) formulated using innovative co-suspension delivery technology, in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) with and without the Aerochamber Plus® Flow-Vu® valved holding chamber (VHC). METHODS: In this multicenter, open-label, crossover, Phase III study (NCT02454959), patients were randomized to receive GFF MDI 14...
May 2018: Respiratory Medicine
https://www.readbyqxmd.com/read/29713156/indacaterol-glycopyrronium-reduces-the-risk-of-clinically-important-deterioration-after-direct-switch-from-baseline-therapies-in-patients-with-moderate-copd-a-post-hoc-analysis-of-the-crystal-study
#5
Timm Greulich, Konstantinos Kostikas, Mina Gaga, Maryam Aalamian-Mattheis, Nadine S Lossi, Francesco Patalano, Xavier Nunez, Veronica A Pagano, Robert Fogel, Claus F Vogelmeier, Andreas Clemens
Purpose: COPD is a progressive disease characterized by exacerbations and a decline in health status and lung function. Clinically important deterioration (CID) is a composite endpoint used to evaluate treatment efficacy. This analysis evaluated the impact of a direct switch to once-daily indacaterol/glycopyrronium 110/50 µg (IND/GLY) from previous monotherapy with a long-acting β2 -agonist (LABA) or long-acting muscarinic antagonist (LAMA) or with an LABA and an inhaled corticosteroid (LABA + ICS) on reducing CID...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29705784/coexisting-heart-failure-and-chronic-obstructive-pulmonary-disease-report-of-two-cases-treated-with-indacaterol-glycopyrronium
#6
Eugenio Roberto Cosentino, Daniela Degli Esposti, Rinaldo Miceli, Crescenzio Bentivenga, Matteo Landolfo, Ilaria Ricci Iamino, Luca Spinardi, Gianluigi Magri, Claudio Borghi
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide, and it is associated with a high economic burden. Heart failure shares some general symptoms with COPD; thus, diagnosing COPD is difficult in subjects with a history of heart failure, and spi-rometry is mandatory for confirmation. Moreover, COPD is a highly prevalent comorbidity negatively impacting the outcome of heart failure patients. We document here the treatment with indacaterol/glycopyrronium in 2 patients with concomitant COPD and heart failure...
2018: Respiration; International Review of Thoracic Diseases
https://www.readbyqxmd.com/read/29705783/combination-therapy-of-inhaled-indacaterol-glycopyrronium-for-chronic-obstructive-pulmonary-disease-in-the-very-elderly-is-it-safe-an-electrocardiographic-evaluation
#7
Francesco Spannella, Federico Giulietti, Valentina Cesari, Antonio Francioso, Guido Cocci, Laura Landi, Francesca Elena Lombardi, Elisabetta Borioni, Beatrice Bernardi, Giulia Rosettani, Valentina Bordoni, Corrado Iacoacci, Piero Giordano, Riccardo Sarzani
Cardiovascular (CV) comorbidities in patients with chronic obstructive pulmonary disease (COPD) are associated with increased morbidity and mortality, especially in old and very old subjects. The question if long-acting beta-agonist and long-acting muscarinic antagonist could be associated with the increased prevalence of CV-related adverse effects has puzzled, particularly in the past, specialists involved in the management of respiratory diseases. The safety of these compounds has scarcely been tested in patients aged ≥ 65 years with CV comorbidities, since randomized controlled trials rarely include this subpopulation...
2018: Respiration; International Review of Thoracic Diseases
https://www.readbyqxmd.com/read/29705782/indacaterol-glycopyrronium-in-the-treatment-of-severe-respiratory-failure-marked-improvement-of-respiratory-failure-in-a-few-weeks-a-case-report
#8
Riccardo Pistelli, Maria Rosaria Castriotti, Loredana Panico
Chronic obstructive pulmonary disease is a highly prevalent disease, especially in the aging population, associated with several functional disabilities and a high economic burden. Dual bronchodilation with prefixed associations of long-acting β2-agonists and long-acting muscarinic antagonist have a significant role in the management of this condition. The newer combination, indacaterol/glycopyrronium, is useful as a once-a-day therapy and has proven superior to other treatment strategies including inhaled corticosteroids for improving symptoms and clinical condition with a very rapid effect...
2018: Respiration; International Review of Thoracic Diseases
https://www.readbyqxmd.com/read/29705781/the-respiratory-overlap-syndrome-efficacy-and-usefulness-of-the-combined-double-bronchodilation
#9
Albino Petrone, Filippo Luca Fimognari, Francesco Mormile, Leonello Fuso, Michela Quartieri, Ludovico Petrone, Francesco Romano
The coexistence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea syndrome in a single patient is known as "overlap syndrome," and worsens the prognosis of the affected subjects. A marked bronchodilation may be useful for the treatment of this condition. In fact, as stated in the GOLD 2017 guidelines, the combination of indacaterol/glycopyrronium may exert positive synergistic effects on smooth muscle cell and airway resistance, with a more pronounced efficiency in reducing lung hyperinflation...
2018: Respiration; International Review of Thoracic Diseases
https://www.readbyqxmd.com/read/29705779/when-two-drugs-are-better-than-three-re-modulating-the-therapeutic-plan-of-a-chronic-obstructive-pulmonary-disease-patient
#10
Antonella Ielpo, Ernesto Crisafulli
We present the case of a 77-year-old man diagnosed with chronic obstructive pulmonary disease (COPD) stage D with emphysema phenotype and treated with triple therapy (salmeterol, fluticasone propionate, and tiotropium) for 1 year without relevant improvements in exertional dyspnea and disease impact. After switching to combination therapy with a long-acting β2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA) (indacaterol/glycopyrronium), we observed, in a 3-month period, a substantial reduction of the modified Medical Research Council (mMRC) dyspnea scale and COPD Assessment Test (CAT) scores...
2018: Respiration; International Review of Thoracic Diseases
https://www.readbyqxmd.com/read/29705778/indacaterol-glycopyrronium-in-clinical-practice-the-italian-experience
#11
Mario Cazzola
No abstract text is available yet for this article.
2018: Respiration; International Review of Thoracic Diseases
https://www.readbyqxmd.com/read/29695902/randomized-double-blind-placebo-controlled-trial-to-assess-the-efficacy-and-safety-of-three-doses-of-co-suspension-delivery-technology-glycopyrronium-mdi-in-japanese-patients-with-moderate-to-severe-copd
#12
Yasushi Fukushima, Yuji Nakatani, Yumiko Ide, Hisakuni Sekino, Earl St Rose, Shahid Siddiqui, Andrea Maes, Colin Reisner
Purpose: Due to the burden of COPD in Japan, new pharmacologic treatments are needed to meet patient requirements. This study assessed the efficacy and safety of glycopyrronium (GP) delivered via metered dose inhaler (MDI) in Japanese patients with moderate-to-severe COPD. Methods: This Phase IIb, multicenter, randomized, double-blind, 7-day, crossover study compared GP MDI 28.8, 14.4, and 7.2 μg with placebo MDI (all administered as two inhalations, twice daily)...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29692733/identification-of-mepenzolate-derivatives-with-long-acting-bronchodilatory-activity
#13
Ken-Ichiro Tanaka, Naoki Yamakawa, Yasunobu Yamashita, Teita Asano, Yuki Kanda, Ayaka Takafuji, Masahiro Kawahara, Mitsuko Takenaga, Yoshifumi Fukunishi, Tohru Mizushima
The standard treatment for chronic obstructive pulmonary disease is a combination of anti-inflammatory drugs and bronchodilators. We recently found that mepenzolate bromide ( MP ), an antagonist for human muscarinic M3 receptor (hM3 R), has both anti-inflammatory and short-acting bronchodilatory activities. To obtain MP derivatives with longer-lasting bronchodilatory activity, we synthesized hybrid compounds based on MP and two other muscarinic antagonists with long-acting bronchodilatory activity glycopyrronium bromide ( GC ) and aclidinium bromide ( AD )...
2018: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29692607/exacerbation-heterogeneity-in-copd-subgroup-analyses-from-the-flame-study
#14
Claus F Vogelmeier, Kenneth R Chapman, Marc Miravitlles, Nicolas Roche, Jørgen Vestbo, Chau Thach, Donald Banerji, Robert Fogel, Francesco Patalano, Petter Olsson, Konstantinos Kostikas, Jadwiga A Wedzicha
Background: The FLAME study compared once-daily indacaterol/glycopyrronium (IND/GLY) 110/50 μg with twice-daily salmeterol/fluticasone (SFC) 50/500 μg in symptomatic patients with moderate to very severe COPD and a history of exacerbations in the previous year. Methods: This prespecified and post hoc subgroup analysis evaluated treatment efficacy on 1) moderate/severe exacerbations according to prior exacerbation history and treatment, and 2) types of exacerbations according to health care resource utilization (HCRU) during 1-year follow-up...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29670345/practical-considerations-when-prescribing-a-long-acting-muscarinic-antagonist-for-patients-with-copd
#15
REVIEW
Anthony D D'Urzo, Peter Kardos, Russell Wiseman
COPD is characterized by persistent airflow limitation, progressive breathlessness, cough, and sputum production. Long-acting muscarinic antagonists (LAMAs) are one of the recommended first-choice therapeutic options for patients with COPD, and several new agents have been developed in recent years. A literature search identified 14 published randomized, placebo-controlled studies of the efficacy and safety of LAMAs in patients with COPD, with improvements seen in lung function, exacerbations, breathlessness, and health status...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29670344/cost-effectiveness-analysis-of-a-fixed-dose-combination-of-indacaterol-and-glycopyrronium-as-maintenance-treatment-for-copd
#16
Ming-Cheng Chan, Elise Chia-Hui Tan, Ming-Chin Yang
Objective: The aim of this study was to evaluate the cost-effectiveness of the long-acting beta-2 agonist (LABA)/long-acting muscarinic antagonist (LAMA) dual bronchodilator indacaterol/glycopyrronium (IND/GLY) as a maintenance treatment for COPD patients from the perspective of health care payer in Taiwan. Patients and methods: We adopted a patient-level simulation model, which included a cohort of COPD patients aged ≥40 years. The intervention used in the study was the treatment using IND/GLY, and comparators were tiotropium or salmeterol/fluticasone combination (SFC)...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29658810/early-changes-in-ediary-copd-symptoms-predict-clinically-relevant-treatment-response-at-12-weeks-analysis-from-the-crystal-study
#17
Konstantinos Kostikas, Maryam Aalamian-Mattheis, Veronica Anna Pagano, Xavier Nunez, Robert Fogel, Francesco Patalano, Andreas Clemens
Early detection of treatment response is important in the long-term treatment and management of patients with chronic obstructive pulmonary disease (COPD). This analysis evaluated whether early improvement in symptoms, recorded in the first 7 or 14 days via an electronic diary (eDiary) compared with baseline, can predict clinically meaningful treatment responders at 12 weeks. CRYSTAL was a 12-week, randomized, open-label study that demonstrated the increased effectiveness of indacaterol/glycopyrronium (IND/GLY) or glycopyrronium (GLY), after a direct switch from on-going baseline therapies, in patients with symptomatic COPD and moderate airflow obstruction...
April 16, 2018: COPD
https://www.readbyqxmd.com/read/29606861/pharmacokinetics-of-glycopyrronium-formoterol-fumarate-dihydrate-delivered-via-metered-dose-inhaler-using-co-suspension-delivery-technology-in-patients-with-moderate-to-very-severe-copd
#18
Gary T Ferguson, Roberto Rodriguez-Roisin, Colin Reisner, Andrea Maes, Shahid Siddiqui, Ubaldo J Martin
Purpose: The efficacy and tolerability of GFF MDI (Bevespi Aerosphere® ), a fixed-dose combination of glycopyrronium (GP)/formoterol fumarate dihydrate (FF) 14.4/10 μg (equivalent to glycopyrrolate/formoterol fumarate 18/9.6 μg) delivered by metered dose inhaler (MDI) using innovative co-suspension delivery technology, has been investigated in a Phase III clinical trial program (NCT01854645, NCT01854658, NCT01970878) in patients with COPD. Here, we present findings from a pharmacokinetic (PK) sub-study of NCT01854645 (PINNACLE-1)...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29546433/cost-effectiveness-of-indacaterol-glycopyrronium-in-comparison-with-salmeterol-fluticasone-combination-for-patients-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-a-lantern-population-analysis-from-singapore
#19
Augustine Tee, Wai Leng Chow, Colin Burke, Guruprasad Basavarajaiah
INTRODUCTION: In light of the growing evidence base for better clinical results with the use of the dual bronchodilator indacaterol/glycopyrronium (IND/GLY) over inhaled corticosteroid-containing salmeterol/fluticasone combination (SFC), this study aimed to evaluate the cost-effectiveness of IND/GLY over SFC in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) who are at low risk of exacerbations in the Singapore healthcare setting. METHODS: A previously published patient-level simulation model was adapted for use in Singapore by applying local unit costs...
March 16, 2018: Singapore Medical Journal
https://www.readbyqxmd.com/read/29544728/the-pharmacokinetics-of-three-doses-of-budesonide-glycopyrronium-formoterol-fumarate-dihydrate-metered-dose-inhaler-compared-with-active-controls-a-phase-i-randomized-single-dose-crossover-study-in-healthy-adults
#20
Patrick Darken, Paolo DePetrillo, Colin Reisner, Earl St Rose, Paul Dorinsky
The budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) is an inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2 -agonist fixed-dose combination formulated with innovative co-suspension delivery technology that is in clinical development for the treatment of chronic obstructive pulmonary disease (COPD). This randomized, Phase I, single-dose, six-treatment, four-period, crossover study (NCT01980615) examined the pharmacokinetic (PK) and safety profile of three doses of BGF MDI (320/14...
March 12, 2018: Pulmonary Pharmacology & Therapeutics
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