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budesonide formoterol

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
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)...
February 5, 2018: Expert Review of Respiratory Medicine
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
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...
January 10, 2018: Lancet Respiratory Medicine
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 8, 2018: Advances in Therapy
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
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
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
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
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
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
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
James Fingleton, Jo Hardy, Christina Baggott, Janine Pilcher, Andrew Corin, Robert J Hancox, Matire Harwood, Mark Holliday, Helen K Reddel, Philippa Shirtcliffe, Suzanne Snively, Mark Weatherall, Richard Beasley
INTRODUCTION: In adult asthma, combination inhaled corticosteroid (ICS)/fast-onset long-acting beta agonist (LABA) used solely as reliever therapy may represent an effective and safe alternative to ICS maintenance and short-acting beta agonist (SABA) reliever therapy. OBJECTIVE: To compare the efficacy and safety of ICS/fast-onset LABA reliever therapy with ICS maintenance and SABA reliever therapy in adults with asthma. METHODS AND ANALYSIS: A 52-week, open-label, parallel group, multicentre, phase III randomised controlled trial with 1:1 randomisation to either budesonide/formoterol Turbuhaler 200/6 µg, one actuation as required for symptom relief, or budesonide Turbuhaler 200 µg, one actuation twice daily and terbutaline Turbuhaler 250 µg, two actuations as required for symptom relief...
2017: BMJ Open Respiratory Research
Y A Salem, M A Shaldam, D T El-Sherbiny, D R El-Wasseef, S M El-Ashry
A simple, accurate and valid ion-pairing chromatographic method was developed for the simultaneous determination of formoterol fumarate (FF) and budesonide (BUD) epimers in metered dose inhaler. The separation was performed on C-18 column using mobile phase consisting of acetonitrile:0.05 M sodium acetate buffer (40:60% v/v) containing 0.03% sodium dodecyl sulfate adjusted to pH 3.1 using increasing volumes of either TEA or orthophosphoric acid isocratically eluted at 1.0 mL/min. Quantitation was achieved with UV detection at 214 nm...
November 1, 2017: Journal of Chromatographic Science
Kristin Palmsten, Avanthi Hulugalle, Gretchen Bandoli, Grace M Kuo, Shayda Ansari, Ronghui Xu, Christina D Chambers
BACKGROUND: There are limited data regarding the comparability of medication exposure information during pregnancy from maternal report and medical records, including for rheumatoid arthritis and asthma-related medications. METHODS: This study included pregnant women with rheumatoid arthritis (n = 216) and asthma (n = 172) enrolled in the MothertoBaby Pregnancy Studies (2009-2014). Women reported types and dates of medications used through semi-structured telephone interviews up to three times during pregnancy and once after delivery, and medical records were obtained...
October 3, 2017: Paediatric and Perinatal Epidemiology
D S Ferreira, R M Carvalho-Pinto, M G Gregório, R Annoni, A M Teles, M Buttignol, B B Araújo-Paulino, E H Katayama, B L Oliveira, H S Del Frari, A Cukier, M Dolhnikoff, R Stelmach, K F Rabe, T Mauad
BACKGROUND: Patients with asthma present structural and inflammatory alterations that are believed to play a role in disease severity. However, airway remodeling and inflammation have not been extensively investigated in relation to both symptom control and airflow obstruction in severe asthmatics. We aimed to investigate several inflammatory and structural pathological features in bronchial biopsies of severe asthmatics that could be related to symptom control and airflow obstruction after standardized treatment...
September 27, 2017: Allergy
Akash Balki, S Balamurugan, Suhas Bardapurkar, Sonia Dalal, Ajeet Singh, B P Singh, Abhijit Vaidya, Jaideep A Gogtay
BACKGROUND: Combination therapy of inhaled corticosteroid/long acting β2-agonist (ICS/LABA) is the cornerstone of managing asthmatics who are uncontrolled with low-medium dose of ICS. The novel ICS/LABA combination of fluticasone propionate and formoterol (flu/form) provides potent anti-inflammatory and rapid bronchodilatory effect. This randomized, multi-centre, double-blind study compared the efficacy and safety of flu/form (125/6 mcg BD; Maxiflo®) with the well-established budesonide/formoterol combination (bud/form 200/6 mcg BD), both delivered through a pressurized metered dose inhaler (pMDI) in patients with moderate to severe persistent asthma over 12 weeks...
September 7, 2017: Pulmonary Pharmacology & Therapeutics
Afisi S Ismaila, Ruby Birk, Dhvani Shah, Shiyuan Zhang, Noushin Brealey, Nancy A Risebrough, Maggie Tabberer, Chang-Qing Zhu, David A Lipson
INTRODUCTION: Chronic obstructive pulmonary disease is associated with a high healthcare resource and cost burden. Healthcare resource utilization was analyzed in patients with symptomatic chronic obstructive pulmonary disease at risk of exacerbations in the FULFIL study. Patients received either once-daily, single inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) 100 µg/62.5 µg/25 µg or twice-daily dual inhaled corticosteroid/long-acting beta agonist therapy (budesonide/formoterol) 400 µg/12 µg...
September 2017: Advances in Therapy
Hsi-Hsing Yang, Chih-Cheng Lai, Ya-Hui Wang, Wei-Chih Yang, Cheng-Yi Wang, Hao-Chien Wang, Likwang Chen, Chong-Jen Yu
BACKGROUND: It remains unclear whether severe exacerbation and pneumonia of COPD differs between patients treated with budesonide/formoterol and those treated with fluticasone/salmeterol. Therefore, we conducted a comparative study of those who used budesonide/formoterol and those treated with fluticasone/salmeterol for COPD. METHODS: Subjects in this population-based cohort study comprised patients with COPD who were treated with a fixed combination of budesonide/formoterol or fluticasone/salmeterol...
2017: International Journal of Chronic Obstructive Pulmonary Disease
Yi-Hua Lin, Xi-Ning Liao, Li-Li Fan, Yue-Jin Qu, De-Yun Cheng, Yong-Hong Shi
BACKGROUND: The systemic inflammation is associated with clinical outcome and mortality in chronic obstructive pulmonary disease (COPD) patients. To investigate the effects of tiotropium (Tio) and/or budesonide/formoterol (Bud/Form) on systemic inflammation biomarkers in stable COPD patients of group D, a randomized, open-label clinical trial was conducted. METHODS: Eligible participants (n = 324) were randomized and received either Tio 18ug once daily (group I), Bud/Form 160/4...
2017: PloS One
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