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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
Glenn A Jacobson, Sharanne Raidal, Kate Robson, Christian K Narkowicz, David S Nichols, E Haydn Walters
BACKGROUND: Salmeterol (a long acting beta2-agonist) is a chiral molecule. (RR)-salmeterol is responsible for pharmacological effect, but basic knowledge of enantioselective pulmonary pharmacodynamics and pharmacokinetics of salmeterol remains unknown. There are safety concerns with (S)-enantiomers of beta2-agonists, with suggestions that these enantiomers may increase bronchial hyperresponsivneness in asthma patients. METHODOLOGY: Horses (n = 12) received racemic (rac-) salmeterol 250 μg via inhalation...
February 23, 2018: Journal of Pharmaceutical and Biomedical Analysis
Merja Kirjavainen, Leena Mattila, Mikko Vahteristo, Jani Korhonen, Satu Lähelmä
BACKGROUND: Easyhaler® dry powder inhaler (DPI) containing salmeterol and fluticasone propionate was developed for the treatment of asthma and chronic obstructive pulmonary disease. Three different Salmeterol/fluticasone Easyhaler test products (Orion Pharma, Finland) were compared against the reference product Seretide® Diskus® DPI (GlaxoSmithKline, United Kingdom) to study whether any of the test products are bioequivalent with the reference. METHODS: Open and randomized pharmacokinetic four-period crossover study on 65 healthy volunteers was performed in a single center to compare the lung deposition and total systemic exposure of salmeterol and fluticasone propionate after administration of single doses (two inhalations of 50/500 μg/inhalation strength) in fasting conditions...
March 1, 2018: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Shin-Hwar Wu, Lih-Jen Shyu, Chin-Hsing Li, Chao-Hung Yu, Huang-Chi Chen, Chew-Teng Kor, Chu-Hsien Wang, Kai-Huang Lin
INTRODUCTION: The optimal dose of inhaled metered-dose bronchodilators for intubated patients with chronic obstructive pulmonary disease (COPD) is unknown. In this study, we proposed a bronchodilator dosing schedule based on an individual's airway resistance (Raw ) and tested its efficacy in reducing Raw . METHODS: A total of 51 newly admitted patients with invasively ventilated COPD were randomly assigned to receive personalized or fixed bronchodilator dosing. Personal target Raw was defined by measuring each individual's Raw after maximal pharmacologic bronchodilatation...
February 20, 2018: Pulmonary Pharmacology & Therapeutics
Nanshan Song, Yinquan Fang, Xiyang Sun, Qingling Jiang, Chenghuan Song, Miaomiao Chen, Jianhua Ding, Ming Lu, Gang Hu
β2-aderenergic receptor (β2AR) agonist, Salmeterol exhibits anti-inflammatory activities. However, the inhibitory effects of Salmeterol on inflammasome activation are elusive and the underlying mechanisms need to be explored. In this study, we established inflammatory model in primary bone marrow-derived macrophages (BMDM) from C57BL/6J mice and β-arrestin2 knockout (β-arrestin2 -/- ) mice in vitro. In vivo study by LPS intraperitoneally (i.p.) in C57BL/6J mice was carried out to ascertain its roles in systemic inflammation...
February 12, 2018: Biochemical Pharmacology
Li Zhang, Guangyin Huang, Long Jin, Shuhua Han
BACKGROUND The aim of this study was to evaluate the therapeutic effects of tiotropium bromide on asthma. MATERIAL AND METHODS A total of 160 patients with moderate persistent asthma were randomly divided into 4 groups (n=40): the 3 control groups were given fluticasone propionate aerosol (group A), salmeterol-fluticasone propionate inhalant (group B), and tiotropium bromide inhalation powder combined with salmeterol-fluticasone propionate inhalant (group C), respectively, and the experimental group received tiotropium bromide inhalation powder combined with fluticasone propionate aerosol (group D) and salbutamol was used to relieve symptoms when necessary...
February 15, 2018: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
Zhiyuan Wang, Chunyan Wang, Xiaoli Yang
Chronic obstructive pulmonary disease (COPD) is a severe lung disease characterized by progressive airflow limitation. Salmeterol and formoterol are two commonly used drugs in COPD therapy, which act as β2-receptor agonists. In the current study, a mouse model of COPD induced by airway lipopolysaccharide inhalation was established. The therapeutic efficacy of salmeterol and formoterol co-treatment was investigated in this model over a 56-day-long observation period. It was also identified that functional residual capacity and inspiratory resistance were significantly improved after salmeterol and/or formoterol treatment compared with the control group (all P<0...
February 2018: Experimental and Therapeutic Medicine
Samy Suissa, Elliot Israel, James Donohue, Scott Evans, James Kemp
The safety of long-acting beta-agonists (LABA) to treat asthma has been a lingering issue for the last 25 years after two large randomized trials reported an increased incidence of asthma death with salmeterol. The current dilemma is whether this risk is also increased when LABAs are given with inhaled corticosteroids (ICS). To address this, the FDA required that manufacturers conduct five large randomized trials comparing ICS-LABA combinations to ICS alone on the incidence of major asthma outcomes. The three trials that have been published to date showed that the risk of a serious asthma-related event, including asthma-related death, intubation or hospitalization, was not increased with the addition of the LABA...
January 22, 2018: American Journal of Respiratory and Critical Care Medicine
Michael E Rezaee, Charlotte E Ward, Bonita Nuanez, Daniel A Rezaee, Jeffrey Ditkoff, Alexandra Halalau
Background: Thirty-day readmission in COPD is common and costly, but potentially preventable. The emergency department (ED) may be a setting for COPD readmission reduction efforts. Objective: To better understand COPD readmission through the ED, ascertain factors associated with 30-day readmission through the ED, and identify subgroups of patients with COPD for readmission reduction interventions. Patients and methods: A retrospective cohort study was conducted from January 2009 to September 2015 in patients with COPD of age ≥18 years...
2018: International Journal of Chronic Obstructive Pulmonary Disease
Glenn A Jacobson, Sharanne Raidal, Morten Hostrup, Luigino Calzetta, Richard Wood-Baker, Mark O Farber, Clive P Page, E Haydn Walters
Long-acting β2-agonists (LABAs) such as formoterol and salmeterol are used for prolonged bronchodilatation in asthma, usually in combination with inhaled corticosteroids (ICSs). Unexplained paradoxical asthma exacerbations and deaths have been associated with LABAs, particularly when used without ICS. LABAs clearly demonstrate effective bronchodilatation and steroid-sparing activity, but long-term treatment can lead to tolerance of their bronchodilator effects. There are also concerns with regard to the effects of LABAs on bronchial hyperresponsiveness (BHR), where long-term use is associated with increased BHR and loss of bronchoprotection...
January 13, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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
Nulma S Jentzsch, Gabriela C G Silva, Guilherme M S Mendes, Paul L P Brand, Paulo Camargos
OBJECTIVE: There is a scarcity of studies that assessed the association between adherence to combination therapy and asthma control in pediatric patients. The authors investigated the association between adherence to fluticasone propionate/salmeterol xinafoate combination-metered aerosol and the level of asthma control in children. METHODS: This was a prospective observational study of 84 patients aged 5-16 years with moderate persistent asthma, who remained uncontrolled despite the use of 1000μg/day of inhaled nonextrafine-hydrofluoric alkane-beclomethasone dipropionate in the three months prior to study enrollment...
December 20, 2017: Jornal de Pediatria
Martin Jetzer, Marcel Schneider, Bradley Morrical, Georgios Imanidis
The potential of the force control agent (FCA) magnesium stearate (MgSt) to enhance the aerosol performance of lactose-based dry powder inhaled (DPI) formulations was investigated in this study. The excipient blends were investigated with analytical techniques including time-of-flight secondary ion mass spectrometry (ToF-SIMS) and Single Particle Aerosol Mass Spectrometry (SPAMS) and particle size, morphology and surface properties were evaluated. Excipient-blends were manufactured either by high-shear or low-shear blending lactose carrier with different amounts of MgSt in the range from 0-10% (w/w)...
December 13, 2017: Journal of Pharmaceutical Sciences
Leif Bjermer, Job F M van Boven, Madlaina Costa-Scharplatz, Dorothy L Keininger, Florian S Gutzwiller, Karin Lisspers, Ronan Mahon, Petter Olsson, Nicolas Roche
BACKGROUND: This study assessed the cost-effectiveness of indacaterol/glycopyrronium (IND/GLY) versus salmeterol/fluticasone (SFC) in chronic obstructive pulmonary disease (COPD) patients with moderate to very severe airflow limitation and ≥1 exacerbation in the preceding year. METHODS: A previously published and validated patient-level simulation model was adapted using clinical data from the FLAME trial and real-world cost data from the ARCTIC study. Costs (total monetary costs comprising drug, maintenance, exacerbation, and pneumonia costs) and health outcomes (life-years (LYs), quality-adjusted life-years (QALYs)) were projected over various time horizons (1, 5, 10 years, and lifetime) from the Swedish payer's perspective and were discounted at 3% annually...
December 11, 2017: Respiratory Research
Cristina Bozzolino, Marta Leporati, Federica Gani, Cinzia Ferrero, Marco Vincenti
A fast analytical method for the simultaneous detection of 24 β2 -agonists in human urine was developed and validated. The method covers the therapeutic drugs most commonly administered, but also potentially abused β2 -agonists. The procedure is based on enzymatic deconjugation with β-glucuronidase followed by SPE clean up using mixed-phase cartridges with both ion-exchange and lipophilic properties. Instrumental analysis conducted by UHPLC-MS/MS allowed high peak resolution and rapid chromatographic separation, with reduced time and costs...
February 20, 2018: Journal of Pharmaceutical and Biomedical Analysis
John M Weiler, Christine A Sorkness, Leslie Hendeles, Sara Nichols, Yaping Zhu
This was a randomized, double-blind, crossover, clinical-end-point pilot study examining the hypothesis that inhaled fluticasone propionate decreases exhaled nitric oxide (eNO) concentrations within a week of beginning treatment and shows evidence of dose separation across the marketed dose range. Subjects had a ≥6-month history of asthma and screening eNO ≥60 parts per billion. At the start of each treatment period, eNO was ≥55 parts per billion, and forced expiratory volume in 1 second was ≥50% predicted...
November 28, 2017: Journal of Clinical Pharmacology
Israel Ramos, Mònica Aparici, Maria Letosa, Carlos Puig, Amadeu Gavaldà, Josep Maria Huerta, Sonia Espinosa, Dolors Vilella, Montserrat Miralpeix
This study describes the association rate and residence time of abediterol, a novel long-acting β2 -adrenoceptor agonist (LABA) in Phase II development for treatment of asthma and COPD, in comparison with indacaterol, olodaterol, vilanterol and salmeterol, for both human β1 - and β2 -adrenoceptors. Abediterol association and dissociation rates were monitored directly by using its tritiated form. Moreover, association was determined indirectly using experimental Ki and koff obtained from assays performed with unlabelled compound...
January 15, 2018: European Journal of Pharmacology
Thomas B Casale, Eric D Bateman, Mark Vandewalker, J Christian Virchow, Hendrik Schmidt, Michael Engel, Petra Moroni-Zentgraf, Huib A M Kerstjens
BACKGROUND: Adding tiotropium to existing inhaled corticosteroid (ICS) maintenance therapy with or without a long-acting β2 -agonist (LABA) has been shown to be beneficial in patients with symptomatic asthma. OBJECTIVE: To assess whether responses to tiotropium Respimat add-on therapy were influenced by patients' T2 status. METHODS: In this exploratory study, data from 4 phase III trials were analyzed: once-daily tiotropium 5 μg or placebo as add-on to ICS + LABA (PrimoTinA-asthma; 2 replicate trials; NCT00772538/NCT00776984; n = 912); once-daily tiotropium 5 μg or 2...
November 22, 2017: Journal of Allergy and Clinical Immunology in Practice
Chun-Yu Lo, Charalambos Michaeloudes, Pankaj K Bhavsar, Chien-Da Huang, Po-Jui Chang, Chun-Hua Wang, Han-Pin Kuo, Kian Fan Chung
BACKGROUND: Patients with severe asthma have increased airway remodelling and elevated numbers of circulating fibrocytes with enhanced myofibroblastic differentiation capacity, despite being treated with high doses of corticosteroids, and long acting β2 -adrenergic receptor (AR) agonists (LABAs). We determined the effect of β2 -AR agonists, alone or in combination with corticosteroids, on fibrocyte function. METHODS: Non-adherent non-T cells from peripheral blood mononuclear cells isolated from healthy subjects and patients with non-severe or severe asthma were treated with the β2 -AR agonist, salmeterol, in the presence or absence of the corticosteroid dexamethasone...
November 21, 2017: Respiratory Research
Maki Kanamori, Gurpreet Dhaliwal, Masami Matsumura, Bradley Monash
A 34-year-old, previously healthy Japanese man developed a dry cough. He did not have dyspnea, nasal discharge, sore throat, facial pain, nasal congestion, or postnasal drip. His symptoms persisted despite several courses of antibiotics (from different physicians), including clarithromycin, minocycline, and levofl oxacin. A chest x-ray after 2 months of symptoms and a noncontrast chest computed tomography (CT) after 4 months of symptoms were normal, and bacterial and mycobacterial sputum cultures were sterile...
October 18, 2017: Journal of Hospital Medicine: An Official Publication of the Society of Hospital Medicine
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