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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
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
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
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
Rafał Ludwikowski, Tadeusz Płusa, Paweł Bijoś
The clinical efficacy of inhaled therapy in patients with asthma and COPD is dependent on the choice of inhaler and proper use of it. The need to instruct patients in the use of the recommended inhaler seems obvious, but in clinical practice is not always followed. AIM: The aim of the study was the comparative evaluation of the selection criteria and the method of instructing in operating the device in asthma and COPD patients. MATERIALS AND METHODS: The study was conducted in 80 patients with asthma and COPD in 9 European countries: France, Germany, Italy, Spain, Great Britain, Holland, Belgium, Denmark, Sweden...
December 22, 2016: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
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
Satu Lähelmä, Mikko Vahteristo, Hristo Metev, Margarita Taseva, Nadezhda Stamatova, Anna Bartha, Judit Schlezák, Ulla Sairanen
BACKGROUND: Therapeutic equivalence of Budesonide/formoterol Easyhaler compared to Symbicort Turbuhaler has been previously demonstrated with in vitro and pharmacokinetic studies. This study was performed to confirm equivalent bronchodilator efficacy of the products in asthmatic patients. METHODS: A randomised, single-dose, 4-period crossover study was carried out in a double-blind, double-dummy manner in 11 study sites. The studied doses were 320/9 μg and 1280/36 μg of budesonide/formoterol delivered by Easyhaler and Turbuhaler...
November 2016: Respiratory Medicine
Ross H M Hatley, Jacob Parker, John N Pritchard, Dirk von Hollen
BACKGROUND: Pressurized metered-dose inhalers (pMDIs) should be shaken before use to prevent creaming or sedimentation of the drugs in solution; however, data published on this topic are limited, and it is rarely specified how soon after shaking the device should be actuated. Delays between shaking and firing the pMDI have previously been shown to cause significant inhomogeneity in delivered dose. We studied the effect of various shake-fire delays on the drug delivered from five commercially available pMDIs commonly prescribed for asthma and chronic obstructive pulmonary disease to assess the potential variability in delivered dose...
February 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Árpád Farkas, Ágnes Jókay, Imre Balásházy, Péter Füri, Veronika Müller, Gábor Tomisa, Alpár Horváth
One of the most widespread dry powder fixed combinations used in asthma and chronic obstructive pulmonary disease (COPD) management is Symbicort(®) Turbuhaler(®). The aim of this study was to simulate the deposition distribution of both components of this drug within the airways based on realistic airflow measurements. Breathing parameters of 25 healthy adults (11 females and 14 males) were acquired while inhaling through Turbuhaler(®). Individual specific emitted doses and particle size distributions of Symbicort(®) Turbuhaler(®) were determined...
October 10, 2016: European Journal of Pharmaceutical Sciences
Eleftherios Zervas, Konstantinos Samitas, Mina Gaga
BACKGROUND: Poor adherence to inhaled therapy is common in patients with asthma and COPD. An inhaler selection based on patients' preference could be beneficial to adherence and treatment effectiveness. Properly designed questionnaires can assess patients' satisfaction with their medication devices. The aim of this study was to estimate, using the Feeling of Satisfaction with Inhaler (FSI-10) questionnaire, the ease of use and satisfaction of patients regarding three different marketed dry powder inhalers (DPIs): Diskus(®) (DK), Elpenhaler(®) (EH), and Turbuhaler(®) (TH)...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Ole D Wolthers
INTRODUCTION: One of the most widely used fixed combinations in asthma management is dry powder budesonide+formoterol fumarate dihydrate which is commercially available as Symbicort Turbuhaler(®) (and generic products), Easyhaler Bufomix(®) and DuoRespSpiromax(®) inhaler. The aim of this paper was to review the fixed dry powder combination of inhaled budesonide+formoterol fumarate dihydrate for asthma treatment in adolescents and adults. AREAS COVERED: A literature search using relevant search terms, reference lists for reviews and meta-analyses was performed...
2016: Expert Opinion on Pharmacotherapy
Soichiro Hozawa, Michikazu Terada, Yoshinori Haruta, Maki Hozawa
BACKGROUND: If asthma patients fail to achieve symptom control using a medium dose of inhaled corticosteroid (ICS) alone, addition of a long-acting β2 agonist (LABA) is the preferred treatment. Currently, there are several combinations of ICS/LABA that are available, each of which has a different property. Here, we aimed to compare the early effects of budesonide/formoterol (BUD/FM; Symbicort(®)) for maintenance and reliever therapy (SMART) with a fixed dose of fluticasone furoate/vilanterol (FF/VI; Relvar(®))...
April 2016: Pulmonary Pharmacology & Therapeutics
Jiangtao Lin, Yan Tang, Qingyu Xiu, Jian Kang, Shaoxi Cai, Kewu Huang, Yohji Itoh, Xia Ling, Nanshan Zhong
BACKGROUND: In the Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia, the effectiveness of single-inhaler budesonide/formoterol maintenance and reliever therapy was evaluated in patients with poorly controlled asthma. OBJECTIVE: To study the effects of this therapy on a Chinese patient subgroup. METHODS: In this 12-week, multicenter, open-label therapeutic phase IV study, patients with partially controlled or uncontrolled asthma were switched from their usual asthma treatment to budesonide/formoterol (160/4...
January 2016: Allergy and Asthma Proceedings:
Janine Pilcher, Philippa Shirtcliffe, Mitesh Patel, Steve McKinstry, Terrianne Cripps, Mark Weatherall, Richard Beasley
BACKGROUND: Electronic monitoring of inhaled asthma therapy is suggested as the 'gold standard' for measuring patterns of medication use in clinical trials. The SmartTurbo (Adherium (NZ) Ltd, Auckland, New Zealand) is an electronic monitor for use with a turbuhaler device (AstraZeneca, UK). The aim of this study was to determine the accuracy of the SmartTurbo in recording Symbicort actuations over a 12-week period of use. METHODS: Twenty SmartTurbo monitors were attached to the base of 20 Symbicort turbuhalers...
2015: BMJ Open Respiratory Research
Francesca Buttini, Gaetano Brambilla, Diego Copelli, Viviana Sisti, Anna Giulia Balducci, Ruggero Bettini, Irene Pasquali
BACKGROUND: European and United States Pharmacopoeia compendial procedures for assessing the in vitro emitted dose and aerodynamic size distribution of a dry powder inhaler require that 4.0 L of air at a pressure drop of 4 kPa be drawn through the inhaler. However, the product performance should be investigated using conditions more representative of what is achievable by the patient population. This work compares the delivered dose and the drug deposition profile at different flow rates (30, 40, 60, and 90 L/min) of Foster NEXThaler(®) (beclomethasone dipropionate/formoterol fumarate), Seretide(®) Diskus(®) (fluticasone propionate/salmeterol xinafoate), and Symbicort(®) Turbohaler(®) (budesonide/formoterol fumarate)...
April 2016: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Anne H de Boer, Doetie Gjaltema, Paul Hagedoorn, Henderik W Frijlink
There is increasing interest in the use of so-called 'extrafine' aerosols to target the small airways in the management of asthma and COPD. Using previously presented deposition data, we assessed whether submicron (<1μm) particles can improve central and deep lung deposition. Our data show instead that particles in the range 1-3μm are much more relevant in this respect. Based on this finding the Symbicort Turbuhaler, Seretide Diskus, Rolenium Elpenhaler and Foster (Fostair) NEXThaler ICS/LABA combination DPIs were tested in vitro as a function of the pressure drop (2, 4 and 6kPa) across the inhaler...
October 2015: European Journal of Pharmaceutics and Biopharmaceutics
Sharon Shui Yee Leung, Patricia Tang, Qi Tony Zhou, Zhenbo Tong, Cassandra Leung, Janwit Decharaksa, Runyu Yang, Hak-Kim Chan
The US pharmacopeia (USP) and Alberta throats were recently reported to cause further de-agglomeration of carrier-free powders emitted from some dry powder inhalers (DPIs). This study assessed if they have similar influences on commercially available carrier-based DPIs. A straight tube, a USP throat, and an Alberta throat (non-coated and coated) were used for cascade impaction testing. Aerosol fine particle fraction (FPF ≤ 5 μm) was computed to evaluate throat-induced de-agglomeration. Computational fluid dynamics are employed to simulate airflow patterns and particle trajectories inside the USP and Alberta throats...
November 2015: AAPS Journal
Lori Weisfeld, Youyi Shu, Tushar P Shah
OBJECTIVE: Budesonide formoterol (BF) Spiromax® is a breath-actuated dry-powder inhaler designed to deliver similar combinations of budesonide and formoterol as Symbicort® Turbohaler®. We performed two studies to demonstrate pharmacokinetic (PK) equivalence of BF Spiromax with BF Turbohaler. MATERIALS AND METHODS: Two single-center, open-label, randomized, 5-period crossover studies were performed. The first study compared BF Spiromax 160/4.5 μg with BF Turbohaler 200/6 μg, while the second study compared BF Spiromax 320/9 μg with BF Turbohaler 400/12 μg...
July 2015: International Journal of Clinical Pharmacology and Therapeutics
Matthew Daubresse, Susan Hutfless, Yoonsang Kim, Rachel Kornfield, Dima M Qato, Jidong Huang, Kay Miller, Sherry L Emery, G Caleb Alexander
RATIONALE: The United States is one of only two countries that permit direct-to-consumer advertising (DTCA) of prescription drugs, and many questions remain regarding its effects. OBJECTIVES: To quantify the association between asthma-related DTCA, pharmacy sales, and healthcare use. METHODS: This was an ecological study from 2005 through 2009 using linked data from Nielsen (DTCA television ratings), the IMS Health National Prescription Audit (pharmacy sales), and the MarketScan Commercial Claims data (healthcare use) for 75 designated market areas in the United States...
July 1, 2015: American Journal of Respiratory and Critical Care Medicine
Satu Lähelmä, Ulla Sairanen, Jussi Haikarainen, Jani Korhonen, Mikko Vahteristo, Rainard Fuhr, Merja Kirjavainen
BACKGROUND: Easyhaler(®) device-metered dry powder inhaler containing budesonide and formoterol fumarate dihydrate (hereafter formoterol) for the treatment of asthma and chronic obstructive pulmonary disease has been developed. The current approvals of the product in Europe were based on several pharmacokinetic (PK) bioequivalence (BE) studies, and in vitro-in vivo correlation (IVIVC) modeling. METHODS: Four PK studies were performed to compare the lung deposition and total systemic exposure of budesonide and formoterol after administration of budesonide/formoterol Easyhaler and the reference product, Symbicort Turbuhaler...
December 2015: Journal of Aerosol Medicine and Pulmonary Drug Delivery
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