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budesonide formoterol

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https://www.readbyqxmd.com/read/29773947/efficacy-safety-and-pharmacokinetics-of-budesonide-formoterol-fumarate-delivered-via-metered-dose-inhaler-using-innovative-co-suspension-delivery-technology-in-patients-with-moderate-to-severe-copd
#1
Edward M Kerwin, Thomas M Siler, Samir Arora, Patrick Darken, Earl Rose, Colin Reisner
Purpose: This study investigated the efficacy, safety, and pharmacokinetics of the inhaled corticosteroid/long-acting β2 -agonist fixed-dose combination budesonide/formoterol fumarate (BFF) metered dose inhaler (MDI), compared with the monocomponents budesonide (BD) MDI and formoterol fumarate (FF) MDI, in patients with moderate-to-severe COPD. Materials and methods: In this Phase IIb, randomized, double-blind, four-period, five-treatment, incomplete-block, crossover study (NCT02196077), all patients received BFF MDI 320/9...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29768149/inhaled-combined-budesonide-formoterol-as-needed-in-mild-asthma
#2
Paul M O'Byrne, J Mark FitzGerald, Eric D Bateman, Peter J Barnes, Nanshan Zhong, Christina Keen, Carin Jorup, Rosa Lamarca, Stefan Ivanov, Helen K Reddel
BACKGROUND: In patients with mild asthma, as-needed use of an inhaled glucocorticoid plus a fast-acting β2 -agonist may be an alternative to conventional treatment strategies. METHODS: We conducted a 52-week, double-blind trial involving patients 12 years of age or older with mild asthma. Patients were randomly assigned to one of three regimens: twice-daily placebo plus terbutaline (0.5 mg) used as needed (terbutaline group), twice-daily placebo plus budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol) used as needed (budesonide-formoterol group), or twice-daily budesonide (200 μg) plus terbutaline used as needed (budesonide maintenance group)...
May 17, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29768147/as-needed-budesonide-formoterol-versus-maintenance-budesonide-in-mild-asthma
#3
Eric D Bateman, Helen K Reddel, Paul M O'Byrne, Peter J Barnes, Nanshan Zhong, Christina Keen, Carin Jorup, Rosa Lamarca, Agnieszka Siwek-Posluszna, J Mark FitzGerald
BACKGROUND: Patients with mild asthma often rely on inhaled short-acting β2 -agonists for symptom relief and have poor adherence to maintenance therapy. Another approach might be for patients to receive a fast-acting reliever plus an inhaled glucocorticoid component on an as-needed basis to address symptoms and exacerbation risk. METHODS: We conducted a 52-week, double-blind, multicenter trial involving patients 12 years of age or older who had mild asthma and were eligible for treatment with regular inhaled glucocorticoids...
May 17, 2018: New England Journal of Medicine
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
#4
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/29762864/population-pharmacokinetic-analysis-of-fluticasone-furoate-umeclidinium-vilanterol-via-a-single-inhaler-in-patients-with-copd
#5
Rashmi Mehta, Eleni Pefani, Misba Beerahee, Noushin Brealey, Helen Barnacle, Ruby Birk, Chang-Qing Zhu, David A Lipson
A population pharmacokinetic analysis was conducted from a subset of samples obtained from the Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy trial to characterize the pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol in patients with symptomatic COPD following treatment with fluticason furoate-umeclidinium-vilanterol combined in a single inhaler. This was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticason furoate-umeclidinium-vilanterol, 100 μg/62...
May 15, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29755809/a-12-week-randomized-parallel-group-phase-iii-study-comparing-the-efficacy-of-once-daily-budesonide-formoterol-turbuhaler-160-4-5-%C3%AE-g-d-with-twice-daily-budesonide-400-%C3%AE-g-d-during-the-step-down-period-in-well-controlled-asthma
#6
Narongwit Nakwan, Thitima Perkleang, Thanida Tamsawai, Pattarawadee Taptawee, Sirikade Usaha
OBJECTIVES: Budesonide/formoterol fumarate (BUD/FF) is recommended in the stepwise management of uncontrolled asthma, but data on a once-daily dose of this medication in a step-down period are lacking. We aimed to compare BUD/FF and BUD in terms of the changes in asthma control scores and lung functions. MATERIAL AND METHODS: This 12-week, randomized, parallel-group, single-center, open-label study was conducted in well-controlled asthmatic patients receiving twice-daily BUD/FF (160/4...
April 2018: Turkish Thoracic Journal
https://www.readbyqxmd.com/read/29750142/single-inhaler-triple-therapy-in-symptomatic-copd-patients-fulfil-subgroup-analyses
#7
David M G Halpin, Ruby Birk, Noushin Brealey, Gerard J Criner, Mark T Dransfield, Emma Hilton, David A Lomas, Chang-Qing Zhu, David A Lipson
Triple inhaled corticosteroid (ICS)/long-acting muscarinic antagonist (LAMA)/long-acting β2 -agonist (LABA) therapy is recommended for symptomatic patients with chronic obstructive pulmonary disease (COPD) and at risk of exacerbations. However, the benefits versus side-effects of triple inhaled therapy for COPD, based on distinct patient clinical profiles, are unclear. FULFIL, a phase III, randomised, double-blind study, compared 24 weeks of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62...
April 2018: ERJ Open Research
https://www.readbyqxmd.com/read/29554195/association-of-inhaled-corticosteroids-and-long-acting-%C3%AE-agonists-as-controller-and-quick-relief-therapy-with-exacerbations-and-symptom-control-in-persistent-asthma-a-systematic-review-and-meta-analysis
#8
Diana M Sobieraj, Erin R Weeda, Elaine Nguyen, Craig I Coleman, C Michael White, Stephen C Lazarus, Kathryn V Blake, Jason E Lang, William L Baker
Importance: Combined use of inhaled corticosteroids and long-acting β-agonists (LABAs) as the controller and the quick relief therapy termed single maintenance and reliever therapy (SMART) is a potential therapeutic regimen for the management of persistent asthma. Objective: To conduct a systematic review and meta-analysis of the effects of SMART in patients with persistent asthma. Data Sources and Study Selection: The databases of MEDLINE via OVID, EMBASE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews were searched from database inception through August 2016 and updated through November 28, 2017...
March 19, 2018: JAMA: the Journal of the American Medical Association
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
#9
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
https://www.readbyqxmd.com/read/29400090/symbicort%C3%A2-maintenance-and-reliever-therapy-smart-and-the-evolution-of-asthma-management-within-the-gina-guidelines
#10
Jiangtao Lin, Xin Zhou, Changzheng Wang, Chuntao Liu, Shaoxi Cai, Mao Huang
The Global Initiative for Asthma (GINA) annual report summarizes the latest evidence for asthma management. GINA recommends stepwise pharmacological treatment, advocating inhaled corticosteroids (ICS) plus rapid, long-acting β2 -agonists (LABA) delivered in a single inhaler for maintenance and relief at Steps 3 (moderate persistent asthma requiring 1-2 controllers plus as-needed reliever), 4 (severe persistent asthma requiring ≥2 controllers plus as-needed reliever), and 5 (higher level care and/or add-on treatment)...
March 2018: Expert Review of Respiratory Medicine
https://www.readbyqxmd.com/read/29370819/single-inhaler-fluticasone-furoate-umeclidinium-vilanterol-versus-fluticasone-furoate-vilanterol-plus-umeclidinium-using-two-inhalers-for-chronic-obstructive-pulmonary-disease-a-randomized-non-inferiority-study
#11
Peter R Bremner, Ruby Birk, Noushin Brealey, Afisi S Ismaila, Chang-Qing Zhu, David A Lipson
BACKGROUND: Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg has been shown to improve lung function and health status, and reduce exacerbations, versus budesonide/formoterol in patients with chronic obstructive pulmonary disease (COPD). We evaluated the non-inferiority of single-inhaler FF/UMEC/VI versus FF/VI + UMEC using two inhalers. METHODS: Eligible patients with COPD (aged ≥40 years; ≥1 moderate/severe exacerbation in the 12 months before screening) were randomized (1:1; stratified by the number of long-acting bronchodilators [0, 1 or 2] per day during run-in) to receive 24-week FF/UMEC/VI 100/62...
January 25, 2018: Respiratory Research
https://www.readbyqxmd.com/read/29331313/predictors-of-exacerbation-risk-and-response-to-budesonide-in-patients-with-chronic-obstructive-pulmonary-disease-a-post-hoc-analysis-of-three-randomised-trials
#12
Mona Bafadhel, Stefan Peterson, Miguel A De Blas, Peter M Calverley, Stephen I Rennard, Kai Richter, Malin Fagerås
BACKGROUND: The peripheral blood eosinophil count might help identify those patients with chronic obstructive pulmonary disease (COPD) who will experience fewer exacerbations when taking inhaled corticosteroids (ICS). Previous post-hoc analyses have proposed eosinophil cutoffs that are both arbitrary and limited in evaluating complex interactions of treatment response. We modelled eosinophil count as a continuous variable to determine the characteristics that determine both exacerbation risk and clinical response to ICS in patients with COPD...
February 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29313286/once-daily-triple-therapy-in-patients-with-copd-patient-reported-symptoms-and-quality-of-life
#13
Maggie Tabberer, David A Lomas, Ruby Birk, Noushin Brealey, Chang-Qing Zhu, Steve Pascoe, Nicholas Locantore, David A Lipson
INTRODUCTION: Directly recorded patient experience of symptoms and health-related quality of life (HRQoL) can complement lung function and exacerbation rate data in chronic obstructive pulmonary disease (COPD) clinical studies. The FULFIL study recorded daily symptoms and activity limitation together with additional patient-reported outcomes of dyspnea and HRQoL, as part of the prespecified analyses. FULFIL co-primary endpoint data have been previously reported. METHODS: FULFIL was a phase III, 24-week, randomized, double-blind, double-dummy, multicenter study comparing once-daily single inhaler triple therapy [fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)] 100 µg/62...
January 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29301922/budesonide-formoterol-maintenance-and-reliever-therapy-in-adolescent-patients-with-asthma
#14
Carin Jorup, Dan Lythgoe, Hans Bisgaard
Asthma control is often suboptimal in adolescents, but few studies have evaluated asthma treatments in this population.This post hoc analysis assessed the efficacy and safety of budesonide/formoterol (BUD/FORM) maintenance and reliever therapy (MART) for treatment of persistent asthma in adolescent (age 12-17 years) subgroups within six randomised, double-blind trials. The primary end-point was time to first severe exacerbation. Secondary end-points included number of severe exacerbations, asthma-related symptoms, night-time awakenings, morning peak expiratory flow, forced expiratory volume in 1 s, as-needed medication use and five-item asthma control questionnaire scores...
January 2018: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/29282192/mast-cell-activation-syndrome
#15
Owen N Kramer, Marla S Barkoff, Claudia Hernandez
A 51-year-old woman with a history of asthma and Hashimoto's thyroiditis presented to the dermatology service with a chief complaint of "itchy bumpy rashes" that persisted beyond 24 hours. She noted that, 3 days prior to the onset of urticaria, a pyrroloquinoline quinone supplement had been started. The urticaria was accompanied by variable episodes of transient facial swelling and difficulty breathing. The patient noted that exposure to fish, nuts, and nonsteroidal anti-inflammatory drugs triggered facial swelling...
2017: Skinmed
https://www.readbyqxmd.com/read/29229103/effect-of-budesonide-formoterol-pressurized-metered-dose-inhaler-on-exacerbations-versus-formoterol-in-chronic-obstructive-pulmonary-disease-the-6-month-randomized-rise-revealing-the-impact-of-symbicort-in-reducing-exacerbations-in-copd-study
#16
Gary T Ferguson, Donald P Tashkin, Tor Skärby, Carin Jorup, Kristina Sandin, Michael Greenwood, Kristine Pemberton, Frank Trudo
BACKGROUND: Prevention of exacerbations is a primary goal for chronic obstructive pulmonary disease (COPD) therapy. This randomized, double-blind, double-dummy, parallel-group, multicenter study evaluated the effect of budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus formoterol dry powder inhaler (DPI) on reducing COPD exacerbations. METHODS: 1219 patients aged ≥40 years with moderate-to-very-severe COPD (per lung function) and a history of ≥1 COPD exacerbation received budesonide/formoterol pMDI 320/9 μg twice daily (BID) during a 4-week run-in...
November 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/29223508/on-the-pharmacokinetics-of-two-inhaled-budesonide-formoterol-combinations-in-asthma-patients-using-modeling-approaches
#17
K Soulele, P Macheras, V Karalis
Dry powder inhalers containing the budesonide/formoterol combination have currently a well-established position among other inhaled products. Even though their efficacy mainly depends on the local concentrations of the drug they deliver within the lungs, their safety profile is directly related to their total systemic exposure. The aim of the present investigation was to explore the absorption and disposition kinetics of the budesonide/formoterol combination delivered via two different dry powder inhalers in asthma patients...
February 2018: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29216852/access-to-affordable-medicines-and-diagnostic-tests-for-asthma-and-copd-in-sub-saharan-africa-the-ugandan-perspective
#18
Davis Kibirige, Leaticia Kampiire, David Atuhe, Raymond Mwebaze, Winceslaus Katagira, Winters Muttamba, Rebecca Nantanda, William Worodria, Bruce Kirenga
BACKGROUND: Equitable access to affordable medicines and diagnostic tests is an integral component of optimal clinical care of patients with asthma and chronic obstructive pulmonary disease (COPD). In Uganda, we lack contemporary data about the availability, cost and affordability of medicines and diagnostic tests essential in asthma and COPD management. METHODS: Data on the availability, cost and affordability of 17 medicines and 2 diagnostic tests essential in asthma and COPD management were collected from 22 public hospitals, 23 private and 85 private pharmacies...
December 8, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/29211140/pharmacotherapeutic-profile-of-users-and-expenditure-on-high-cost-drugs-in-s%C3%A3-o-leopoldo-rio-grande-do-sul-state-brazil-2014
#19
Mariani Sopelsa, Fabiane Raquel Motter, Nêmora Tregnago Barcellos, Heloísa Marquardt Leite, Vera Maria Vieira Paniz
OBJECTIVE: to describe the pharmacotherapeutic profile of users of the Specialized Program for Pharmaceutical Assistance, and to measure the expenditure on the most prevalent and the most expensive medications. METHODS: descriptive study conducted in São Leopoldo-RS, Brazil, with secondary data regarding information about requests accepted in 2014, through administrative proceedings; delivery notes of the State Health Department/RS were used to assess the costs...
October 2017: Epidemiologia e Servicos de Saude: Revista do Sistema Unico de Saude do Brasil
https://www.readbyqxmd.com/read/29119403/evaluation-of-the-efficiency-of-single-inhaler-combination-therapy-with-budesonide-formoterol-fumarate-in-patients-with-bronchial-asthma-in-daily-clinical-practice
#20
Michał Pirożyński, Piotr Hantulik, Agnieszka Almgren-Rachtan, Jerzy Chudek
INTRODUCTION: The effectiveness of single-inhaler budesonide/formoterol fumarate combination therapy for asthma has been previously shown for the original product. The aim of this nonrandomized, open-label, postauthorization efficacy study (PAES) real-life clinical assessment was to evaluate the clinical effectiveness of a second product (Bufomix Easyhaler® ) in the daily clinical practice of asthma therapy. METHODS: This multicenter PAES was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49...
December 2017: Advances in Therapy
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