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https://www.readbyqxmd.com/read/28427541/long-term-safety-and-efficacy-of-glycopyrrolate-formoterol-metered-dose-inhaler-using-novel-co-suspension%C3%A2-delivery-technology-in-patients-with-chronic-obstructive-pulmonary-disease
#1
Nicola A Hanania, Donald P Tashkin, Edward M Kerwin, James F Donohue, Michael Denenberg, Denis E O'Donnell, Dean Quinn, Shahid Siddiqui, Chad Orevillo, Andrea Maes, Colin Reisner
BACKGROUND: The long-term safety and efficacy of a novel Co-Suspension™ Delivery Technology glycopyrrolate (GP)/formoterol fumarate (FF) 18/9.6 μg fixed-dose combination metered dose inhaler (GFF MDI) were investigated in a 28-week safety extension study (PINNACLE-3, NCT01970878) of two randomized controlled Phase III trials (PINNACLE-1 and -2; NCT01854645 and NCT01854658) in subjects with moderate-to-very severe chronic obstructive pulmonary disease (COPD). METHODS: Subjects completing 24 weeks' treatment with GFF MDI, GP MDI, FF MDI (all twice-daily) or open-label tiotropium 18 μg (once-daily) in PINNACLE-1 or -2 were randomly selected to continue treatment for 28 weeks...
May 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28427362/efficacy-of-budesonide-formoterol-maintenance-and-reliever-therapy-compared-with-higher-dose-budesonide-as-step-up-from-low-dose-inhaled-corticosteroid-treatment
#2
Christine R Jenkins, Göran Eriksson, Eric D Bateman, Helen K Reddel, Malcolm R Sears, Magnus Lindberg, Paul M O'Byrne
BACKGROUND: Asthma management may involve a step up in treatment when symptoms are not well controlled. We examined whether budesonide/formoterol maintenance and reliever therapy (MRT) is as effective as higher, fixed-dose budesonide plus as-needed terbutaline in patients requiring step-up from Step 2 treatment (low-dose inhaled corticosteroids), stratified by baseline reliever use. METHODS: A post-hoc analysis utilized data from three clinical trials of 6-12 months' duration...
April 20, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/28414142/doxofylline-does-not-increase-formoterol-induced-camp-nor-mkp-1-expression-in-asm-cells-resulting-in-lack-of-anti-inflammatory-effect
#3
Brijeshkumar S Patel, Michael J Kugel, Gina Baehring, Alaina J Ammit
The xanthine doxofylline has been examined in clinical trials and shown to have efficacy and greater tolerability than theophylline in asthma and chronic obstructive pulmonary disease. The 'novofylline' doxofylline has demonstrated bronchodilatory and anti-inflammatory actions in in vivo and ex vivo experimental models of respiratory disease. However, there are limited studies in vitro. We address this herein and examine whether doxofylline has anti-inflammatory impact on primary cultures of airway smooth muscle (ASM) cells...
April 13, 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28387094/-formoterol-budesonide-combination-for-maintenance-and-relief-in-children-and-adolescents-with-asthma
#4
REVIEW
G de Bilderling, D Smal, E Bradatan
International guidelines have been edited to standardize asthma management. These guidelines are often difficult to translate to clinical practice because of gaps in the knowledge of clinical practitioners but also because of compliance issues, particularly in children and adolescents. A new approach named SIT (for Single Inhaler Therapy) or SMART (for Symbicort Maintenance and Reliever Therapy) has demonstrated its safety and efficacy in numerous studies of adults with asthma summarized in two Cochrane reviews...
December 2016: Revue Médicale de Liège
https://www.readbyqxmd.com/read/28385353/single-inhaler-extrafine-triple-therapy-versus-long-acting-muscarinic-antagonist-therapy-for-chronic-obstructive-pulmonary-disease-trinity-a-double-blind-parallel-group-randomised-controlled-trial
#5
Jørgen Vestbo, Alberto Papi, Massimo Corradi, Viktor Blazhko, Isabella Montagna, Catherine Francisco, Géraldine Cohuet, Stefano Vezzoli, Mario Scuri, Dave Singh
BACKGROUND: Limited 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 compared treatment with extrafine beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB; fixed triple) with tiotropium, and BDP/FF plus tiotropium (open triple). METHODS: For this double-blind, parallel-group, randomised, controlled trial, eligible patients had COPD, post-bronchodilator forced expiratory volume in 1 s (FEV1) of less than 50%, at least one moderate-to-severe COPD exacerbation in the previous 12 months, and a COPD Assessment Test total score of at least 10...
April 3, 2017: Lancet
https://www.readbyqxmd.com/read/28383629/ip-10-in-occupational-asthma-review-of-the-literature-and-case-control-study
#6
F Ragusa, P Fallahi
OBJECTIVES: T-helper (Th)2 cytokines are thought to mediate most of the allergic inflammatory responses associated with atopic asthma. But the Th1-related chemokine, interferon (IFN)-γ-induced protein 10 (IP-10)/chemokine (C-X-C motif) ligand (CXCL)10, was the predominant chemokine measured during human allergic pulmonary late-phase reaction. Viral infection and allergens can exacerbate asthma by inducing the accumulation of these chemokines and inflammatory cells in the airway. Short-acting β2-adrenoreceptor agonists, budesonide and formoterol (all important relievers in asthma exacerbation), such as vitamin D3, vitamin C, have been shown to inhibit airway cells inflammatory responses by modulating these chemokines...
March 2017: La Clinica Terapeutica
https://www.readbyqxmd.com/read/28375647/fulfil-trial-once-daily-triple-therapy-in-patients-with-chronic-obstructive-pulmonary-disease
#7
David A Lipson, Helen Barnacle, Ruby Birk, Noushin Brealey, Nicholas Locantore, David A Lomas, Andrea Ludwig-Sengpiel, Rajat Mohindra, Maggie Tabberer, Chang-Qing Zhu, Steven J Pascoe
RATIONALE: Randomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy in patients with chronic obstructive pulmonary disease (COPD) are limited. OBJECTIVES: We compared the effects of once-daily triple therapy on lung function and health-related quality of life with twice-daily ICS/LABA therapy. METHODS: FULFIL was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticasone furoate/umeclidinium/vilanterol 100 μg/62...
April 4, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28351782/a-randomized-pragmatic-trial-of-changing-to-and-stepping-down-fluticasone-formoterol-in-asthma
#8
Omar S Usmani, Anu Kemppinen, Elizabeth Gardener, Vicky Thomas, Priyanka Raju Konduru, Christina Callan, Andrew McLoughlin, Vanessa Woodhead, Adam Brady, Elizabeth F Juniper, Peter J Barnes, David Price
BACKGROUND: Guidelines recommend reducing treatment in patients with well-controlled asthma after 3 months of stability. However, there is inadequate real-life data to guide physicians on therapy change in daily practice. OBJECTIVE: To assess asthma control after change to and step-down of fluticasone propionate/formoterol fumarate dihydrate (FP/FOR) in real-life patients. METHODS: In a randomized controlled, pragmatic, open-label trial, 225 well-controlled patients with asthma were randomized (1:2) to maintain high-dose fluticasone propionate/salmeterol xinafoate (FP/SAL, 1000/100 μg) or switch to FP/FOR (1000/40 μg) daily for 12 weeks (phase 1)...
March 25, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28351669/effect-of-maximum-inhalation-flow-and-inhaled-volume-on-formoterol-drug-deposition-in-vitro-from-an-easyhaler%C3%A2-dry-powder-inhaler
#9
Mohamad Abadelah, Firisteh Hazim, Henry Chrystyn, Golshan Bagherisadeghi, Hassan Rahmoune, Hassan Larhrib
Most patients using dry powder inhalers (DPIs) do not achieve the inhalation parameters recommended for pharmacopoeial in-vitro dose emission testing. The dose emission characteristics of formoterol from an Easyhaler have been measured using the Andersen Cascade Impactor (ACI) with a maximum inhalation flow (MIF) of 28.3, 60 and 90L/min and inhaled volumes (Vin) of 240, 750, 1500 and 2000mL. The total emitted dose (TED) was significantly higher at 90L/min (p<0.05), but the difference in the TED between low (28...
March 25, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28340862/symptom-variability-and-control-in-copd-advantages-of-dual-bronchodilation-therapy
#10
REVIEW
Fabiano Di Marco, Pierachille Santus, Nicola Scichilone, Paolo Solidoro, Marco Contoli, Fulvio Braido, Angelo Guido Corsico
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a heterogeneous disorder characterized by usually progressive development of airflow obstruction that is not fully reversible. While most patients will experience symptoms throughout the day or in the morning upon awakening, many patients do not experience their symptoms as constant but report variability in symptoms during the course of the day or over time. Symptom variability adversely affects patients' health status and increases the risk of COPD exacerbations...
April 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28340861/a-randomised-double-blind-placebo-controlled-long-term-extension-study-of-the-efficacy-safety-and-tolerability-of-fixed-dose-combinations-of-aclidinium-formoterol-or-monotherapy-in-the-treatment-of-chronic-obstructive-pulmonary-disease
#11
Anthony D'Urzo, Stephen Rennard, Edward Kerwin, James F Donohue, Alejhandra Lei, Eduard Molins, Anne Leselbaum
INTRODUCTION: Aclidinium bromide/formoterol fumarate (AB/FF) 400/12 μg efficacy and safety was demonstrated in two 6-month Phase III studies (AUGMENT and ACLIFORM) and a 12-month study in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This Phase III, double-blind, placebo-controlled, 6-month AUGMENT extension investigated the long-term safety and tolerability of AB/FF 400/12 μg (NCT01572792). METHODS: Patients were randomised in AUGMENT (1:1:1:1:1) to twice-daily AB/FF 400/12 μg, AB/FF 400/6 μg, AB 400 μg, FF 12 μg or placebo...
April 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28295605/peri-meatal-pein-and-urethral-scc-a-case-report
#12
LETTER
P R Doiron, H P Menage, A Freeman, A Muneer, C B Bunker
No abstract text is available yet for this article.
March 10, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28283554/impaired-dual-specificity-protein-phosphatase-dusp4-reduces-corticosteroid-sensitivity
#13
Yoshiki Kobayashi, Kazuhiro Ito, Akira Kanda, Koich Tomoda, Nicolas Mercado, Peter Barnes
We have reported that phosphorylation of glucocorticoid receptor (GR) at Ser(226) reduces GR nuclear translocation resulting in corticosteroid insensitivity in patients with severe asthmas. A serine/threonine protein phosphatase, PP2A, which regulates JNK1 and GR-Ser(226) signaling, is involved in this mechanism. Here, we further explored dual-specificity protein kinases (DUSPs) with the ability to dephosphorylate JNK, and identified DUSP4 as a phosphatase involved in the regulation of corticosteroid sensitivity...
March 10, 2017: Molecular Pharmacology
https://www.readbyqxmd.com/read/28258535/routine-use-of-budesonide-formoterol-fixed-dose-combination-in-elderly-asthmatic-patients-practical-considerations
#14
Nicola Scichilone, Fulvio Braido, Federico Lavorini, Mark L Levy, Omar S Usmani
Asthma has been demonstrated to be as common in the elderly as in younger age groups. Although no specific recommendations exist to manage the disease differently in older individuals, functional features and clinical presentations may be affected by age per se, and by age-related conditions, such as comorbidities and polypharmacy. In this review article, we aimed to explore the efficacy and safety in elderly asthmatic patients of one of the most currently used inhaled treatments for asthma, that is, the fixed-dose combination of budesonide/formoterol...
March 4, 2017: Drugs & Aging
https://www.readbyqxmd.com/read/28257236/human-rhinovirus-infection-of-epithelial-cells-modulates-airway-smooth-muscle-migration
#15
Sami Shariff, Christopher Shelfoon, Neil S Holden, Suzanne L Traves, Shahina Wiehler, Cora Kooi, David Proud, Richard Leigh
RATIONALE: Airway remodeling, a characteristic feature of asthma, begins in early life. Recurrent human rhinovirus (HRV) infections are a potential inciting stimulus for remodeling. One component of airway remodeling is an increase in airway smooth muscle cell mass with a greater proximity of the airway smooth muscle cells (ASMC) to the airway epithelium. We asked whether human bronchial epithelial cells infected with HRV produced mediators that are chemotactic for ASMC. METHODS: ASMC migration was investigated using the modified Boyden Chamber and the xCELLigence Real-Time Cell Analyzer...
March 3, 2017: American Journal of Respiratory Cell and Molecular Biology
https://www.readbyqxmd.com/read/28256307/efficacy-and-safety-of-budesonide-formoterol-pmdi-vs-budesonide-pmdi-in-asthmatic-children-6-12-years
#16
David S Pearlman, Göran Eckerwall, Julie McLaren, Rosa Lamarca, Margareta Puu, Ileen Gilbert, Carin Jorup, Kristina Sandin, Miguel J Lanz
BACKGROUND: The efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI) have been demonstrated in patients with asthma at least 12 years old. OBJECTIVE: To evaluate the efficacy of 2 formoterol doses added to budesonide as fixed combinations vs budesonide alone in children 6 to younger than 12 years with asthma. METHODS: This randomized, double-blinded, parallel-group, multicenter study (NCT02091986; CHASE 3) included children 6 to younger than 12 years with asthma previously receiving a medium-dose inhaled corticosteroid (ICS) or an ICS plus a long-acting β2-agonist...
April 2017: Annals of Allergy, Asthma & Immunology
https://www.readbyqxmd.com/read/28254655/real-life-dose-emission-characterization-using-copd-patient-inhalation-profiles-when-they-inhaled-using-a-fixed-dose-combination-fdc-of-the-medium-strength-symbicort-%C3%A2-turbuhaler-%C3%A2
#17
Golshan Bagherisadeghi, El Hassane Larhrib, Henry Chrystyn
The dose emitted from dry powder inhalers (DPI) is inhalation flow dependent and so varies with the peak inhalation flow (PIF) of a patient's inhalation maneuver (IM). Dose emission could also be affected by other IM parameters-the inhaled volume (Vin) and the initial acceleration rate of the IM (ACIM). We have adapted the compendial method for in-vitro DPI determinations so that inhalation profiles replace the inhalation square profile generated by a vacuum pump. These real-life patient inhalation profiles were measured when 18 COPD patients inhaled through an empty placebo Symbicort(®) Turbuhaler(®)...
February 28, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28240689/randomized-clinical-trial-of-a-combination-of-an-inhaled-corticosteroid-and-beta-agonist-in-patients-at-risk-of-developing-the-acute-respiratory-distress-syndrome
#18
Emir Festic, Gordon E Carr, Rodrigo Cartin-Ceba, Richard F Hinds, Valerie Banner-Goodspeed, Vikas Bansal, Adijat T Asuni, Daniel Talmor, Govindarajan Rajagopalan, Ryan D Frank, Ognjen Gajic, Michael A Matthay, Joseph E Levitt
OBJECTIVES: Effective pharmacologic treatments directly targeting lung injury in patients with the acute respiratory distress syndrome are lacking. Early treatment with inhaled corticosteroids and beta agonists may reduce progression to acute respiratory distress syndrome by reducing lung inflammation and enhancing alveolar fluid clearance. DESIGN: Double-blind, randomized clinical trial (ClinicalTrials.gov: NCT01783821). The primary outcome was longitudinal change in oxygen saturation divided by the FIO2 (S/F) through day 5...
May 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28235977/use-of-concomitant-inhaled-corticosteroids-pooled-data-from-two-phase-iii-studies-of-aclidinium-plus-formoterol-in-copd
#19
Anthony D'Urzo, Dave Singh, Esther Garcia Gil
Bronchodilator therapy is the backbone of the management of chronic obstructive pulmonary disease. In some patients, inhaled corticosteroids can be prescribed in combination with bronchodilators. Through a subgroup analysis of pooled data from two large phase III clinical trials of bronchodilator therapy according to concomitant inhaled corticosteroid use (user vs. non-user), we sought to evaluate the clinical benefit of adding inhaled corticosteroids to dual bronchodilator therapy in chronic obstructive pulmonary disease...
December 2017: NPJ Primary Care Respiratory Medicine
https://www.readbyqxmd.com/read/28228660/estimating-the-economic-consequences-of-an-increased-medication-adherence-due-to-a-potential-improvement-in-the-inhaler-technique-with-spiromax-%C3%A2-compared-with-turbuhaler-%C3%A2-in-patients-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-in-spain
#20
Josep Darbà, Gabriela Ramírez, Juan L García-Rivero, Sagrario Mayoralas, José Francisco Pascual, Diego Vargas, Adi Bijedic
OBJECTIVE: The objective of this study was to estimate the economic impact of the introduction of DuoResp(®) Spiromax(®), budesonide/formoterol fixed-dose combination (FDC), focusing on an increase in medication adherence due to an enhancement of the inhalation technique for the treatment of COPD patients in Spain and 5 regions including Andalusia, Catalonia, Galicia, Madrid, and Valencia. METHODS: A 4-year budget impact model was developed for the time period of 2015-2018...
2017: ClinicoEconomics and Outcomes Research: CEOR
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