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https://www.readbyqxmd.com/read/28069068/the-sygma-programme-of-phase-3-trials-to-evaluate-the-efficacy-and-safety-of-budesonide-formoterol-given-as-needed-in-mild-asthma-study-protocols-for-two-randomised-controlled-trials
#1
Paul M O'Byrne, J Mark FitzGerald, Nanshan Zhong, Eric Bateman, Peter J Barnes, Christina Keen, Gun Almqvist, Kristine Pemberton, Carin Jorup, Stefan Ivanov, Helen K Reddel
BACKGROUND: In many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation, with poor control of asthma symptoms and increased risk of exacerbations. The use of budesonide/formoterol 'as needed' in response to symptoms may represent an alternative treatment option for patients with mild asthma...
January 10, 2017: Trials
https://www.readbyqxmd.com/read/28065679/acute-cardiovascular-safety-of-two-formulations-of-beclometasone-dipropionate-formoterol-fumarate-in-copd-patients-a-single-dose-randomised-placebo-controlled-crossover-study
#2
Dave Singh, Giorgia Ciurlia, Annalisa Piccinno, Annamaria Muraro, Maria Bocchi, Mario Scuri
INTRODUCTION: An extrafine combination of beclometasone dipropionate (BDP) and formoterol fumarate (FF) via a pressurised metered-dose inhaler (pMDI) has been commercially available for some years for the management of asthma and chronic obstructive pulmonary disease (COPD). A dry powder inhaler (DPI) formulation of extrafine BDP/FF is now also available. This study evaluated the cardiovascular safety of BDP/FF DPI in comparison to BDP/FF pMDI and placebo. METHODS: Single-dose, partially-blind, randomised, placebo-controlled, 5-period crossover study...
January 5, 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28061907/a-randomized-seven-day-study-to-assess-the-efficacy-and-safety-of-a-glycopyrrolate-formoterol-fumarate-fixed-dose-combination-metered-dose-inhaler-using-novel-co-suspension%C3%A2-delivery-technology-in-patients-with-moderate-to-very-severe-chronic-obstructive-pulmonary
#3
Colin Reisner, Leonardo M Fabbri, Edward M Kerwin, Charles Fogarty, Selwyn Spangenthal, Klaus F Rabe, Gary T Ferguson, Fernando J Martinez, James F Donohue, Patrick Darken, Earl St Rose, Chad Orevillo, Shannon Strom, Tracy Fischer, Michael Golden, Sarvajna Dwivedi
BACKGROUND: Long-acting muscarinic antagonist/long-acting β2-agonist combinations are recommended for patients whose chronic obstructive pulmonary disease (COPD) is not managed with monotherapy. We assessed the efficacy and safety of glycopyrrolate (GP)/formoterol fumarate (FF) fixed-dose combination delivered via a Co-Suspension™ Delivery Technology-based metered dose inhaler (MDI) (GFF MDI). METHODS: This was a Phase IIb randomized, multicenter, placebo-controlled, double-blind, chronic-dosing (7 days), crossover study in patients with moderate-to-very severe COPD ( NCT01085045 )...
January 6, 2017: Respiratory Research
https://www.readbyqxmd.com/read/28056550/co-inhalation-of-roflumilast-rather-than-formoterol-with-fluticasone-more-effectively-improves-asthma-in-asthmatic-mice
#4
Hussam A Murad, Hamed S Habib, Misbahuddin M Rafeeq, Mansour I Sulaiman, Amer S Abdulrahman, Mohamad Nidal Khabaz
Roflumilast is approved as an add-on therapy for chronic obstructive pulmonary disease. The inflammation in chronic obstructive pulmonary disease is mainly neutrophilic, while in asthma it is mainly eosinophilic, studies addressing role of roflumilast in eosinophilic inflammation are recommended. Also in severe asthma, the dominant inflammatory cells are neutrophils. Thus, roflumilast has a potential off-label use in the treatment of asthma. This study was designed to evaluate the effects of co-inhalation of roflumilast and fluticasone compared to that of formoterol and fluticasone in ovalbumin-sensitized and-challenged BALB/c mice...
January 1, 2017: Experimental Biology and Medicine
https://www.readbyqxmd.com/read/28051147/%C3%AE-2-adrenoreceptor-inverse-agonist-down-regulates-muscarine-cholinergic-subtype-3-receptor-and-its-downstream-signal-pathways-in-airway-smooth-muscle-cells-in-vitro
#5
Jian Luo, Yuan-Hua Liu, Wei Luo, Zhu Luo, Chun-Tao Liu
Mechanisms underlying β2-adrenoreceptor (β2AR) inverse agonist mediated bronchoprotectiveness remain unknown. We incubated ICI118,551, formoterol, budesonide, and formoterol plus budesonide, as well as ICI118,551 or pindolol plus formoterol, ICI118,551 plus forskolin, SQ22,536 or H89 plus formoterol in ASMCs to detect expressions of M3R, PLCβ1 and IP3. The level of M3R in the presence of 10(-5) mmol/L ICI118,551 were significantly decreased at 12 h, 24 h and 48 h (P < 0.05), and at 24 h were significantly reduced in ICI118,551 with concentration of 10(-5 )mmol/L, 10(-6 )mmol/L, 10(-7 )mmol/L, and 10(-8 )mmol/L (P < 0...
January 4, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28041995/osteoprotegerin-and-%C3%AE-2-agonists-mitigate-muscular-dystrophy-in-slow-and-fast-twitch-skeletal-muscles
#6
Sébastien S Dufresne, Antoine Boulanger-Piette, Jérôme Frenette
Our recent work showed that daily injections of osteoprotegerin (OPG)-immunoglobulin fragment complex (OPG-Fc) completely restore the function of fast-twitch extensor digitorum longus muscles in dystrophic mdx mice, a murine model of Duchenne muscular dystrophy. However, despite marked improvements, OPG-Fc was not as effective in preventing the loss of function of slow-twitch soleus and diaphragm muscles. Because β2-agonists enhance the function of slow- and fast-twitch dystrophic muscles and because their use is limited by their adverse effects on bone and cardiac tissues, we hypothesized that OPG-Fc, a bone and skeletal muscle protector, acts synergistically with β2-agonists and potentiates their positive effects on skeletal muscles...
December 30, 2016: American Journal of Pathology
https://www.readbyqxmd.com/read/28039105/long-acting-%C3%AE-2-agonists-promote-glucocorticoid-mediated-repression-of-nf-%C3%AE%C2%BAb-by-enhancing-expression-of-the-feedback-regulator-tnfaip3
#7
Mohammed Omar Altonsy, Mahmoud M Mostafa, Anthony N Gerber, Robert Newton
Glucocorticoids, or corticosteroids, are effective treatments for many chronic inflammatory diseases and, in mild/moderate asthma, long-acting β2-adrenoceptor agonists (LABAs) enhance the efficacy of inhaled corticosteroids (ICSs) more than increasing the ICS dose. In human bronchial epithelial, BEAS-2B, cells, expression of TNFα-induced protein 3 (TNFAIP3), or A20, a dual-ubiquitin ligase that provides feedback inhibition of NF-κB, was induced by budesonide, an ICS, formoterol, a LABA, and was further enhanced by budesonide/formoterol combination...
December 29, 2016: American Journal of Physiology. Lung Cellular and Molecular Physiology
https://www.readbyqxmd.com/read/28031707/early-efficacy-of-budesonide-formoterol-in-patients-with-moderate-to-very-severe-copd
#8
Peter M Calverley, Göran Eriksson, Christine R Jenkins, Antonio R Anzueto, Barry J Make, Anders Persson, Malin Fagerås, Dirkje S Postma
BACKGROUND AND OBJECTIVE: Large clinical trials have confirmed the long-term efficacy of inhaled corticosteroid/long-acting β2-agonist combinations in patients with chronic obstructive pulmonary disease (COPD). It was hypothesized that significant treatment effects would already be present within 3 months after the initiation of treatment across a range of clinical outcomes, irrespective of COPD severity. METHODS: Post hoc analysis of 3-month post-randomization outcomes, including exacerbation rates, dropouts, symptoms, reliever use, and lung function, from three studies with similar inclusion criteria of moderate-to-very-severe COPD...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28025073/nano-and-microstructured-model-carrier-surfaces-to-alter-dry-powder-inhaler-performance
#9
Niklas Renner, Hartwig Steckel, Nora Urbanetz, Regina Scherließ
The present study investigates the effect of different carrier surface modifications on the aerosolisation performance and on the effective carrier payload of interactive blends for inhalation. Two different active pharmaceutical ingredients (APIs) were used: Formoterol fumarate dihydrate (FF) and budesonide (BUD). Blends were prepared with glass beads as model carriers which have been subjected to mechanical surface modifications in order to introduce surface roughness via treatment with hydrofluoric acid (HF) and/or milling with tungsten carbide (TC)...
December 23, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27997807/roflumilast-n-oxide-in-combination-with-formoterol-enhances-the-anti-inflammatory-effect-of-dexamethasone-in-asm-cells
#10
Brijeshkumar S Patel, Md Mostafizur Rahman, Gina Baehring, Dikaia Xenaki, Francesca Su-May Tang, Brian G Oliver, Alaina J Ammit
Roflumilast is an orally active phosphodiesterase 4 (PDE4) inhibitor approved for use in chronic obstructive pulmonary disease. Roflumilast N-oxide (RNO) is the active metabolite of roflumilast and has demonstrated anti-inflammatory impact in vivo and in vitro. To date, the effect of RNO on the synthetic function of airway smooth muscle (ASM) cells is unknown. We address this herein and investigate the effect of RNO on β2-adrenoceptor-mediated, cAMP-dependent responses in ASM cells in vitro, and whether RNO enhances steroid-induced repression of inflammation...
December 20, 2016: American Journal of Respiratory Cell and Molecular Biology
https://www.readbyqxmd.com/read/27992923/adding-glycopyrronium-to-beclomethasone-plus-formoterol-improved-pulmonary-function-in-copd
#11
Brian Budenholzer
No abstract text is available yet for this article.
December 20, 2016: Annals of Internal Medicine
https://www.readbyqxmd.com/read/27972275/the-potential-to-improve-inhalation-technique-in-patients-with-asthma-or-copd-by-switching-from-symbicort%C3%A2-turbuhaler%C3%A2-budesonide-formoterol-to-duoresp%C3%A2-spiromax%C3%A2-estimated-impact-on-the-number-and-cost-of-unscheduled-healthcare-events-in-poland
#12
A Watson, P Bijos, R Ludwikowski, A Lewis, M Blackney, S Torvinen, A Plich
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27971531/a-12-week-cost-analysis-to-compare-fluticasone-furoate-vilanterol-and-beclomethasone-dipropionate-formoterol-in-the-treatment-of-mild-to-moderate-asthma
#13
R W Dal Negro, C Distante, L Bonadiman, P Turco, S Iannazzo
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27971520/real-life-persistence-of-budesonide-formoterol-spiromax-for-the-management-of-asthma-and-copd-in-the-uk
#14
H Benhaddi, M Van Der Tol, D Price, M Batsiou, R Ariely
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27965772/once-daily-fluticasone-furoate-vilanterol-versus-twice-daily-combination-therapies-in-asthma-mixed-treatment-comparisons-of-clinical-efficacy
#15
Henrik Svedsater, Gillian Stynes, Jaro Wex, Lucy Frith, David Leather, Emanuela Castelnuovo, Michelle Detry, Scott Berry
BACKGROUND: Fluticasone furoate (FF)/vilanterol (VI) is a once-daily inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) combination. FF/VI, 92/22mcg and 184/22mcg, are approved in Europe as maintenance therapy in persistent asthma. We report data from mixed treatment comparisons (MTC) of once-daily FF/VI against established twice-daily ICS/LABA combination therapies on clinical efficacy outcomes. METHODS: Data from 31 parallel-group randomised controlled trials (RCTs) of ICS/LABA, of ≥8 weeks' duration in patients aged ≥12 years with asthma, identified by systematic review, were analysed using covariate-adjusted Bayesian hierarchical models for four efficacy outcomes (primary analysis)...
2016: Asthma research and practice
https://www.readbyqxmd.com/read/27938358/high-strength-extrafine-pmdi-beclometasone-formoterol-200-6%C3%A2-%C3%AE-g-is-effective-in-asthma-patients-not-adequately-controlled-on-medium-high-dose-of-inhaled-corticosteroids
#16
Pierluigi Paggiaro, Massimo Corradi, Manuela Latorre, Helene Raptis, Annamaria Muraro, Christian Gessner, Zenon Siergiejko, Mario Scuri, Stefano Petruzzelli
BACKGROUND: A high strength of beclomethasone/formoterol fumarate (BDP/FF) in a pressurised metered dose inhaler (pMDI), which contains extrafine BDP (200 μg/actuation) and FF (6 μg/actuation) has been developed to treat those asthmatics who are not adequately controlled on previous treatments. METHODS: A 12-week, randomized, double-blind, parallel group study was performed to compare the efficacy and safety of pMDI BDP/FF 200/6 (two actuations bid) with BDP 100 μg (four actuation bid) in a population of 376 randomized adult asthmatics not adequately controlled with high dose of inhaled corticosteroids (ICS) or medium dose of ICS plus long acting β2agonists (LABA)...
December 9, 2016: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/27931302/new-insights-into-treatment-of-children-with-exercise-induced-asthma-symptoms
#17
Iwona Stelmach, Anna Sztafiska, Joanna Jerzyska, Daniela Podlecka, Pawe Majak, Wodzimierz Stelmach
BACKGROUND: Exercise is one of the most common triggers of bronchoconstriction and affects up to 80% of children with asthma. OBJECTIVE: The purpose of this randomized, double-blind, placebo-controlled study was to assess the effectiveness of treatment with ciclesonide 160 microgram, either alone, with a higher dose, with a leukotriene receptor antagonist (LTRA), or with a long-acting beta-agonist (LABA) in children with asthma with postexercise-induced symptoms...
November 2016: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/27916620/efficacy-and-safety-of-glycopyrrolate-formoterol-mdi-formulated-using-co-suspension%C3%A2-delivery-technology-in-patients-with-copd
#18
Fernando J Martinez, Klaus F Rabe, Gary T Ferguson, Leonardo M Fabbri, Stephen Rennard, Gregory J Feldman, Sanjay Sethi, Selwyn Spangenthal, Gregory M Gottschlich, Roberto Rodriguez-Roisin, Samir Arora, Thomas M Siler, Shahid Siddiqui, Patrick Darken, Tracy Fischer, Andrea Maes, Michael Golden, Chad Orevillo, Colin Reisner
BACKGROUND: Long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) combinations are a treatment option for patients with chronic obstructive pulmonary disease (COPD) who continue to have symptoms despite treatment with a LAMA or LABA alone. OBJECTIVES: The PINNACLE-1 (NCT01854645) and -2 (NCT01854658) trials investigated the efficacy and safety of a novel GFF MDI (glycopyrrolate [GP]/formoterol [FF] 18/9.6 μg metered dose inhaler [MDI]) formulated using Co-Suspension™ Delivery Technology, in patients with moderate-to-very severe COPD...
December 1, 2016: Chest
https://www.readbyqxmd.com/read/27916196/adaptive-activation-of-a-stress-response-pathway-improves-learning-and-memory-through-gs-and-%C3%AE-arrestin-1-regulated-lactate-metabolism
#19
Jun-Hong Dong, Yi-Jing Wang, Min Cui, Xiao-Jing Wang, Wen-Shuai Zheng, Ming-Liang Ma, Fan Yang, Dong-Fang He, Qiao-Xia Hu, Dao-Lai Zhang, Shang-Lei Ning, Chun-Hua Liu, Chuan Wang, Yue Wang, Xiang-Yao Li, Fan Yi, Amy Lin, Alem W Kahsai, Thomas Joseph Cahill, Zhe-Yu Chen, Xiao Yu, Jin-Peng Sun
BACKGROUND: Stress is a conserved physiological response in mammals. Whereas moderate stress strengthens memory to improve reactions to previously experienced difficult situations, too much stress is harmful. METHODS: We used specific β-adrenergic agonists, as well as β2-adrenergic receptor (β2AR) and arrestin knockout models, to study the effects of adaptive β2AR activation on cognitive function using Morris water maze and object recognition experiments. We used molecular and cell biological approaches to elucidate the signaling subnetworks...
October 13, 2016: Biological Psychiatry
https://www.readbyqxmd.com/read/27877031/the-association-between-inhaled-corticosteroid-and-pneumonia-in-copd-patients-the-improvement-of-patients-life-quality-with-copd-in-taiwan-impact-study
#20
Cheng-Yi Wang, Chih-Cheng Lai, Wei-Chih Yang, Chia-Chieh Lin, Likwang Chen, Hao-Chien Wang, Chong-Jen Yu
To investigate the association between inhaled corticosteroid (ICS) exposure patterns and the risk of pneumonia in chronic obstructive pulmonary disease (COPD) patients, we performed a nested case-control study. Between 1998 and 2010, 51,739 patients, including 19,838 cases of pneumonia, were matched to 74,849 control subjects selected from a cohort of COPD patients using ICSs via risk-set sampling of the database constructed by the National Health Research Institutes of Taiwan. After adjusting for covariates, the current use of ICSs was associated with a 25% increase in the risk of pneumonia (odds ratio [OR] =1...
2016: International Journal of Chronic Obstructive Pulmonary Disease
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