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budesonide formoterol

Dario Gulin, Jozica Sikic, Jasna Cerkez Habek, Sandra Jerkovic Gulin, Edvard Galic
Eosinophilic myocarditis (EM) is a rare and potentially fatal disease if left untreated. Because the disease can have a delayed presentation and can appear even after 2 years, its underlying causes often remain unknown. We report the case of a 63-year-old man with an atypical clinical presentation of hypersensitive EM and significant coronary artery disease, which was confirmed through coronary angiography. The patient was treated with hydrochlorothiazide (12.5 mg once daily for 2 years) and budesonide/formoterol (160/4...
December 2016: Drug Saf Case Rep
Kazutaka Mori, Tomoyuki Fujisawa, Naoki Inui, Dai Hashimoto, Noriyuki Enomoto, Yutaro Nakamura, Shigeki Kuroishi, Koshi Yokomura, Mikio Toyoshima, Shiro Imokawa, Takashi Yamada, Toshihiro Shirai, Masafumi Masuda, Hiroshi Hayakawa, Kingo Chida, Takafumi Suda
BACKGROUND: The stepping down of asthma treatment can be considered when asthma symptoms have been well controlled with inhaled corticosteroids (ICSs)/long-acting β2 adrenergic agonists (LABAs). However, few data are available comparing the efficacy between two step-down strategies, to reduce ICS/LABA dose or to withdraw LABA continuing ICS, in well-controlled asthmatics. METHODS: This was a prospective multicentre randomized, two-arm, controlled study. Ninety-one asthmatic patients controlled by budesonide/formoterol combination (BFC) 320/9 μg twice daily were assigned to 2 stepping-down treatments as follows: the BFC group; BUD/FM 160/4...
October 2016: Respiratory Medicine
Josep Darbà, Gabriela Ramírez, Juan L García-Rivero, Sagrario Mayoralas-Alises, José Francisco Pascual, Albert Roger, Diego Vargas, Adi Bijedic
OBJECTIVE: To assess the economic impact of the introduction of DuoResp(®) Spiromax(®) by focusing on a potential improvement in the inhalation technique to strengthen medication adherence for the treatment of moderate to severe asthmatics in Spain and five Spanish regions including Andalusia, Catalonia, Galicia, Madrid, and Valencia. METHODS: A 4-year budget impact model was developed for the period 2015-2018 from the Spanish Healthcare System perspective. Budesonide-formoterol fixed-dose combination delivered by Turbuhaler(®) was considered to be the most appropriate comparator for assessing the budget impact with the introduction of DuoResp(®) Spiromax(®)...
2016: ClinicoEconomics and Outcomes Research: CEOR
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...
September 16, 2016: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Feisal A Al-Kassimi, Esam H Al-Hamad, Mohammed S Al-Hajjaj, Emad Raddaoui, Abdulaziz H Alzeer, Ahmad A Alboukai, Ali M Somily, Joseph G Cal, Abdalla F Ibrahim, Shaffi A Shaik
BACKGROUND AND OBJECTIVE: Post-mortem and computed tomography (CT) studies indicated that emphysema is a feature of COPD even in the 'blue bloater/chronic bronchitis' type. We aim to test the hypothesis that the non-emphysematous patients are distinct from the main body of COPD and are more akin to asthmatic patients. METHODS: We studied 54 patients with COPD. Emphysema was measured by Goddard's visual scoring of CT scan and the carbon monoxide transfer coefficient (KCO)...
September 13, 2016: Respirology: Official Journal of the Asian Pacific Society of Respirology
Stephen P Peters, Eugene R Bleecker, Giorgio W Canonica, Yong B Park, Ricardo Ramirez, Sally Hollis, Harald Fjallbrant, Carin Jorup, Ubaldo J Martin
BACKGROUND: Concerns remain about the safety of adding long-acting β2-agonists to inhaled glucocorticoids for the treatment of asthma. In a postmarketing safety study mandated by the Food and Drug Administration, we evaluated whether the addition of formoterol to budesonide maintenance therapy increased the risk of serious asthma-related events in patients with asthma. METHODS: In this multicenter, double-blind, 26-week study, we randomly assigned patients, 12 years of age or older, who had persistent asthma, were receiving daily asthma medication, and had had one to four asthma exacerbations in the previous year to receive budesonide-formoterol or budesonide alone...
September 1, 2016: New England Journal of Medicine
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
Paolo Montuschi, Mario Malerba, Giuseppe Macis, Nadia Mores, Giuseppe Santini
Combining individual drugs in a single inhaler is the most convenient way to deliver triple therapy. A long-acting muscarinic receptor antagonist (LAMA) added to an inhaled corticosteroid (ICS)/long-acting β2-adrenoceptor agonist (LABA) fixed-dose combination (FDC) can improve efficacy of pharmacological treatment of patients with chronic obstructive pulmonary disease (COPD). New inhaled ICS/LABA/LAMA FDCs, including fluticasone furoate/vilanterol/umeclidinium, budesonide/formoterol/glycopyrronium and beclometasone/formoterol/glycopyrronium, are in Phase III of clinical development for COPD...
July 21, 2016: Drug Discovery Today
Samir Gupta, Emily Paolucci, Alan Kaplan, Louis-Philippe Boulet
Background. Several international groups develop asthma guidelines. Conflicting recommendations across guidelines have been described in several disease areas and may contribute to practice variability. Accordingly, we compared the latest Canadian Thoracic Society (CTS) asthma guideline with contemporaneous international asthma guidelines to evaluate conflicting recommendations and their causes. Methods. We identified the latest CTS asthma guideline update (2012) and the following societies which also updated their guidelines in 2012: the British Thoracic Society and Scottish Intercollegiate Guidelines Network and the Global Initiative for Asthma...
2016: Canadian Respiratory Journal: Journal of the Canadian Thoracic Society
Rachael L DiSantostefano, Nada Boudiaf, David A Stempel, Neil C Barnes, Andrew P Greening
Inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combinations are recommended regular maintenance options for asthma. ICS/LABAs containing formoterol may also be indicated for single maintenance and reliever therapy (SMART). This analysis evaluated the frequency of SMART dosing of budesonide/formoterol fixed-dose combination (BFC) in the United Kingdom. Secondary objectives were to assess adherence and use of short-acting ß2-agonists (SABAs). This was a descriptive analysis of treatment patterns using the UK Clinical Practice Research Datalink-GP OnLine Database data (2009-2013)...
2016: NPJ Primary Care Respiratory Medicine
A Lewis, S Torvinen, P N R Dekhuijzen, H Chrystyn, A T Watson, M Blackney, A Plich
BACKGROUND: Asthma and chronic obstructive pulmonary disease (COPD) are common chronic inflammatory respiratory diseases, which impose a substantial burden on healthcare systems and society. Fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA), often administered using dry powder inhalers (DPIs), are frequently prescribed to control persistent asthma and COPD. Use of DPIs has been associated with poor inhalation technique, which can lead to increased healthcare resource use and costs...
2016: BMC Health Services Research
Mario Cazzola, Josuel Ora, Alessanda Di Paolo, Ermanno Puxeddu, Luigino Calzetta, Paola Rogliani
Budesonide/formoterol (BF) is available in two delivery systems, the dry powder inhaler (DPI) Turbuhaler and a pressurized metered dose inhaler (pMDI) for use in patients with asthma or chronic obstructive pulmonary disease (COPD). Spiromax DPI was recently developed as an alternative to Turbuhaler DPI. In the present study, we examined whether there is a difference in the onset of bronchodilatation between BF 320/9 μg delivered by Spiromax and BF 320/9 μg delivered by Turbuhaler in 16 outpatients with stable moderate-to-severe COPD...
August 2016: Pulmonary Pharmacology & Therapeutics
Ana R Sousa, John H Riley, Alison Church, Chang-Qing Zhu, Yogesh S Punekar, William A Fahy
Benefits of triple therapy with a long-acting muscarinic antagonist (LAMA), added to inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA), have been demonstrated. Limited data assessing the efficacy of the LAMA umeclidinium (UMEC) added to ICS/LABA are available. The aim of this study is to evaluate the efficacy and safety of UMEC added to ICS/LABAs in patients with moderate-to-very-severe COPD. This is a multicentre, randomised, double-blind, parallel-group study. Patients were symptomatic (modified Medical Research Council Dyspnoea Scale score ⩾2), despite receiving ICS/LABA (fluticasone propionate/salmeterol (FP/SAL, branded) 500/50 mcg, budesonide/formoterol (BD/FOR, branded) 200/6 mcg or 400/12 mcg, or other ICS/LABAs) ⩾30 days before the run-in (7±2 days)...
2016: NPJ Primary Care Respiratory Medicine
Sei Won Kim, Chin Kook Rhee, Yoo Jin Kim, Seok Lee, Hee Je Kim, Jong Wook Lee
BACKGROUND: Bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic stem cell transplantation (HSCT) is currently treated with systemic corticosteroids despite poor efficacy and side effects. This study investigated the therapeutic effect of budesonide/formoterol, montelukast and n-acetylcysteine, which are suggested as treatment options for BOS after HSCT. METHODS: After diagnosis of BOS, 61 patients were treated with budesonide/formoterol, montelukast and n-acetylcysteine for 3 months...
2016: Respiratory Research
Alberto Papi, Adel H Mansur, Tetyana Pertseva, Kirsten Kaiser, Tammy McIver, Birgit Grothe, Sanjeeva Dissanayake
BACKGROUND: A primary goal of asthma management is the reduction of exacerbation risk. We assessed the occurrence of oral corticosteroid-requiring exacerbations (OCS exacerbations) with long-term fluticasone/formoterol therapy, and compared it with the occurrence of similar events reported with other inhaled corticosteroid/long acting β2-agonist (ICS/LABA) combinations. METHODS: The occurrence of OCS exacerbations was assessed in two open-label trials of fixed-dose fluticasone/formoterol administered for between 26 to 60 weeks in adults and adolescents with asthma...
August 2016: Journal of Aerosol Medicine and Pulmonary Drug Delivery
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
Donald P Tashkin, Gary E Moore, Frank Trudo, Michael DePietro, Bradley E Chipps
BACKGROUND: The consistency of fixed airflow limitation status during treatment in patients with asthma is unknown. OBJECTIVE: The objective of this study was to determine the consistency of fixed airflow obstruction (FAO) status during treatment and effects on treatment response. METHODS: This post hoc analysis from a 12-week study (NCT00652002) assessed patients aged 12 years or more with moderate-to-severe asthma randomized to twice-daily budesonide/formoterol (BUD/FM) via pressurized metered-dose inhaler (pMDI) 320/9 μg, BUD pMDI 320 μg, FM 9 μg via dry-powder inhaler, or placebo...
July 2016: Journal of Allergy and Clinical Immunology in Practice
Jill R Davis, David M Kern, Setareh A Williams, Ozgur Tunceli, Bingcao Wu, Sally Hollis, Charlie Strange, Frank Trudo
BACKGROUND: Chronic obstructive pulmonary disease (COPD) affects approximately 15 million people in the United States and accounts for approximately $36 billion in economic burden, primarily due to medical costs. To address the increasing clinical and economic burden, the Global Initiative for Chronic Obstructive Lung Disease emphasizes the use of therapies that help prevent COPD exacerbations, including inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA). OBJECTIVE: To evaluate health care costs and utilization among COPD patients newly initiating ICS/LABA combination therapy with budesonide/formoterol (BFC) or fluticasone/salmeterol (FSC) in a managed care system...
March 2016: Journal of Managed Care & Specialty Pharmacy
J Christian Virchow, Roberto Rodriguez-Roisin, Alberto Papi, Tushar P Shah, Gokul Gopalan
BACKGROUND: Budesonide and formoterol (BF) Spiromax® is a dry powder inhaler designed to deliver BF with maximum ease of use for patients with asthma or chronic obstructive pulmonary disease. METHODS: A phase 3b, 12-week, multicenter, double-blind, double-dummy, randomized, controlled trial in patients (≥12 years) with persistent asthma. PRIMARY OBJECTIVE: to demonstrate non-inferiority of twice-daily BF Spiromax 160/4.5 mcg to BF Turbuhaler® 200/6 mcg in change from baseline in weekly average of daily trough morning peak expiratory flow (PEF)...
2016: BMC Pulmonary Medicine
Peter M Calverley, Dirkje S Postma, Antonio R Anzueto, Barry J Make, Göran Eriksson, Stefan Peterson, Christine R Jenkins
BACKGROUND: Early treatment response markers, for example, improvement in forced expiratory volume in 1 second (FEV1) and St George's Respiratory Questionnaire (SGRQ) total score, may help clinicians to better manage patients with chronic obstructive pulmonary disease (COPD). We investigated the prevalence of clinically important improvements in FEV1 and SGRQ scores after 2-month budesonide/formoterol or formoterol treatment and whether such improvements predict subsequent improvements and exacerbation rates...
2016: International Journal of Chronic Obstructive Pulmonary Disease
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