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https://www.readbyqxmd.com/read/29989511/lung-deposition-of-the-dry-powder-fixed-combination-beclometasone-dipropionate-plus-formoterol-fumarate-using-nexthaler-%C3%A2-device-in-healthy-subjects-asthmatic-patients-and-copd-patients
#1
Johann Christian Virchow, Gianluigi Poli, Christiane Herpich, Claudius Kietzig, Hilke Ehlich, Daniela Braeutigam, Knut Sommerer, Sabine Häussermann, Fabrizia Mariotti
BACKGROUND: This study evaluated the lung deposition and the distribution pattern in the airways of a fixed combination of beclometasone dipropionate (BDP) and formoterol fumarate (FF) (100/6 μg) delivered as an extrafine dry powder formulation (mass median aerodynamic diameter, MMAD (μm) BDP = 1.5; FF = 1.4) through the NEXThaler® device in healthy subjects, asthmatics, and patients with COPD. METHODS: Healthy subjects (n = 10), asthmatic patients (n = 9; 30%≤FEV1 < 80%), and COPD patients (n = 9; FEV1 /FVC ≤70%, 30%≤FEV1 < 50%) completed this open-label, single administration (inhalation of four actuations) parallel group study...
July 10, 2018: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/29985096/single-inhaler-triple-therapy-with-extrafine-beclomethasone-formoterol-and-glycopyrronium-for-the-treatment-of-chronic-obstructive-pulmonary-disease
#2
Dave Singh
Chronic obstructive pulmonary disease (COPD) management focuses on the alleviation of symptoms and prevention of exacerbations. Inhaled long acting bronchodilators and inhaled corticosteroids (ICS) are the main classes of treatment for COPD. Triple therapy with a long acting beta2 -agonist (LABA), long acting muscarinic antagonist (LAMA), and ICS is commonly prescribed for symptomatic COPD patients experiencing regular exacerbations. Triple therapy is usually administered using separate inhalers; there is little clinical trial evidence of an effect on exacerbation prevention with this approach...
August 13, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29429593/extrafine-inhaled-triple-therapy-versus-dual-bronchodilator-therapy-in-chronic-obstructive-pulmonary-disease-tribute-a-double-blind-parallel-group-randomised-controlled-trial
#3
Alberto Papi, Jørgen Vestbo, Leonardo Fabbri, Massimo Corradi, Hélène Prunier, Géraldine Cohuet, Alessandro Guasconi, Isabella Montagna, Stefano Vezzoli, Stefano Petruzzelli, Mario Scuri, Nicolas Roche, Dave Singh
BACKGROUND: Evidence is scarce on the relative risk-benefit of inhaled triple therapy, consisting of inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting β2 -agonist, versus dual bronchodilation for chronic obstructive pulmonary disease (COPD). We aimed to compare a single-inhaler triple combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G) versus a single-inhaler dual bronchodilator combination of indacaterol plus glycopyrronium (IND/GLY) in terms of the rate of moderate-to-severe COPD exacerbations over 52 weeks of treatment...
March 17, 2018: Lancet
https://www.readbyqxmd.com/read/29337185/proliposome-tablets-manufactured-using-a-slurry-driven-lipid-enriched-powders-development-characterization-and-stability-evaluation
#4
Iftikhar Khan, Sakib Yousaf, Sneha Subramanian, Mohamed Albed Alhnan, Waqar Ahmed, Abdelbary Elhissi
Proliposome powders were prepared via a slurry method using sorbitol or D-mannitol as carbohydrate carriers in 1:10 or 1:15 w/w lipid phase to carrier ratios. Soya phosphatidylcholine (SPC) and cholesterol were employed as a lipid phase and Beclometasone dipropionate (BDP) was incorporated as a model drug. Direct compaction using a Minipress was applied on the lipid-enriched powder in order to manufacture proliposome tablets. Sorbitol-based proliposome tablets in a 1:15 w/w ratio were found to be the best formulation as it exhibited excellent powder flowability with an angle of repose of 25...
March 1, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29237699/single-inhaler-triple-therapy-for-copd
#5
(no author information available yet)
The European Medicines Agency (EMA) has granted marketing authorisation for a pressurised metered dose inhaler (pMDI) containing beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium bromide (Trimbow - Chiesi Pharmaceuticals) for the treatment of chronic obstructive pulmonary disease (COPD) in patients not adequately treated with a combination of an inhaled corticosteroid (ICS) and a long-acting beta2 agonist (LABA).1-3 The manufacturer claims that this is a significant treatment advance for COPD patients, and that the use of one inhaler should simplify therapy and, therefore, may improve adherence...
December 2017: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/29217600/asthma-phenotypes-do-cough-and-wheeze-predict-exacerbations-in-persistent-asthma
#6
Jaymin B Morjaria, Alan S Rigby, Alyn H Morice
Little is known of the long-term symptom profile in uncontrolled asthma and whether symptoms can predict distinct phenotypes. The primary objective of these analyses was to assess diurnal profile of cough and wheeze in an uncontrolled asthma population. Secondary outcomes were to examine how these symptom profiles influence response to treatment.Twice-daily electronically recorded data from 1701 patients were examined in relation to the population demographics. Reliever treatment with salbutamol was then compared with extra-fine beclometasone/formoterol maintenance and reliever therapy (MART)...
December 2017: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/29030687/tolerability-of-bisoprolol-on-domiciliary-spirometry-in-copd
#7
Sunny Jabbal, Brian J Lipworth
We investigated if serial domiciliary measures of spirometry were sensitive at detecting subtle effects of beta-2 blockade associated with bisoprolol in (n = 17) patients with COPD. After a two-week run in on inhaled corticosteroid (ICS) and long acting beta-2 agonist (LABA): beclometasone/formoterol 100/6 µg, patients' started additional a long acting muscarinic receptor antagonist: (LAMA) Tiotropium 18 µg, with concomitant weekly dose titration of bisoprolol: 1.25-2.5-5 mg. After a further week of bisoprolol 5 mg, they were stepped back down to (ICS/LABA) for one week...
February 2018: Lung
https://www.readbyqxmd.com/read/28744115/bronchodilator-efficacy-of-extrafine-glycopyrronium-bromide-the-glyco-2-study
#8
RANDOMIZED CONTROLLED TRIAL
Dave Singh, Mario Scuri, Sara Collarini, Stefano Vezzoli, Fabrizia Mariotti, Annamaria Muraro, Daniela Acerbi
An extrafine formulation of the long-acting muscarinic antagonist glycopyrronium bromide (GB) is in development for chronic obstructive pulmonary disease (COPD), in combination with beclometasone dipropionate and formoterol fumarate - a "fixed triple". This two-part study was randomized, double blind, placebo controlled in patients with moderate-to-severe COPD: Part 1: single-dose escalation, GB 12.5, 25, 50, 100 or 200 μg versus placebo; Part 2: repeat-dose (7-day), four-period crossover, GB 12...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28698930/proliposome-powders-for-the-generation-of-liposomes-the-influence-of-carbohydrate-carrier-and-separation-conditions-on-crystallinity-and-entrapment-of-a-model-antiasthma-steroid
#9
Iftikhar Khan, Sakib Yousaf, Sneha Subramanian, Mohamed Albed Alhnan, Waqar Ahmed, Abdelbary Elhissi
Formulation effects on the entrapment of beclometasone dipropionate (BDP) in liposomes generated by hydration of proliposomes were studied, using the high-density dispersion medium deuterium oxide in comparison to deionized water (DW). Proliposomes incorporating BDP (2 mol% of the lipid phase consisting of soya phosphatidylcholine (SPC) and cholesterol; 1:1) were manufactured, using lactose monohydrate (LMH), sorbitol or D-mannitol as carbohydrate carriers (1:5 w/w lipid to carrier). Following hydration of proliposomes, separation of BDP-entrapped liposomes from the unentrapped (free) BDP at an optimized centrifugation duration of 90 min and a centrifugation force of 15,500g were identified...
January 2018: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28385353/single-inhaler-extrafine-triple-therapy-versus-long-acting-muscarinic-antagonist-therapy-for-chronic-obstructive-pulmonary-disease-trinity-a-double-blind-parallel-group-randomised-controlled-trial
#10
Jørgen Vestbo, Alberto Papi, Massimo Corradi, Viktor Blazhko, Isabella Montagna, Catherine Francisco, Géraldine Cohuet, Stefano Vezzoli, Mario Scuri, Dave Singh
BACKGROUND: Limited data are available for the efficacy of triple therapy with two long-acting bronchodilators and an inhaled corticosteroid in chronic obstructive pulmonary disease (COPD). We compared treatment with extrafine beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB; fixed triple) with tiotropium, and BDP/FF plus tiotropium (open triple). METHODS: For this double-blind, parallel-group, randomised, controlled trial, eligible patients had COPD, post-bronchodilator forced expiratory volume in 1 s (FEV1 ) of less than 50%, at least one moderate-to-severe COPD exacerbation in the previous 12 months, and a COPD Assessment Test total score of at least 10...
May 13, 2017: Lancet
https://www.readbyqxmd.com/read/28065679/acute-cardiovascular-safety-of-two-formulations-of-beclometasone-dipropionate-formoterol-fumarate-in-copd-patients-a-single-dose-randomised-placebo-controlled-crossover-study
#11
RANDOMIZED CONTROLLED TRIAL
Dave Singh, Giorgia Ciurlia, Annalisa Piccinno, Annamaria Muraro, Maria Bocchi, Mario Scuri
INTRODUCTION: An extrafine combination of beclometasone dipropionate (BDP) and formoterol fumarate (FF) via a pressurised metered-dose inhaler (pMDI) has been commercially available for some years for the management of asthma and chronic obstructive pulmonary disease (COPD). A dry powder inhaler (DPI) formulation of extrafine BDP/FF is now also available. This study evaluated the cardiovascular safety of BDP/FF DPI in comparison to BDP/FF pMDI and placebo. METHODS: Single-dose, partially-blind, randomised, placebo-controlled, 5-period crossover study...
February 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27938358/high-strength-extrafine-pmdi-beclometasone-formoterol-200-6-%C3%AE-g-is-effective-in-asthma-patients-not-adequately-controlled-on-medium-high-dose-of-inhaled-corticosteroids
#12
RANDOMIZED CONTROLLED TRIAL
Pierluigi Paggiaro, Massimo Corradi, Manuela Latorre, Helene Raptis, Annamaria Muraro, Christian Gessner, Zenon Siergiejko, Mario Scuri, Stefano Petruzzelli
BACKGROUND: A high strength of beclomethasone/formoterol fumarate (BDP/FF) in a pressurised metered dose inhaler (pMDI), which contains extrafine BDP (200 μg/actuation) and FF (6 μg/actuation) has been developed to treat those asthmatics who are not adequately controlled on previous treatments. METHODS: A 12-week, randomized, double-blind, parallel group study was performed to compare the efficacy and safety of pMDI BDP/FF 200/6 (two actuations bid) with BDP 100 μg (four actuation bid) in a population of 376 randomized adult asthmatics not adequately controlled with high dose of inhaled corticosteroids (ICS) or medium dose of ICS plus long acting β2 agonists (LABA)...
December 9, 2016: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/27598678/single-inhaler-triple-therapy-versus-inhaled-corticosteroid-plus-long-acting-%C3%AE-2-agonist-therapy-for-chronic-obstructive-pulmonary-disease-trilogy-a-double-blind-parallel-group-randomised-controlled-trial
#13
RANDOMIZED CONTROLLED TRIAL
Dave Singh, Alberto Papi, Massimo Corradi, Ilona Pavlišová, Isabella Montagna, Catherine Francisco, Géraldine Cohuet, Stefano Vezzoli, Mario Scuri, Jørgen Vestbo
BACKGROUND: Few data are available for the efficacy of "triple therapy" with two long-acting bronchodilators and an inhaled corticosteroid in chronic obstructive pulmonary disease (COPD). We designed this study to assess efficacy of single-inhaler combination of an extra fine formulation of beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) in COPD compared with beclometasone dipropionate and formoterol fumarate (BDP/FF) treatment. METHODS: TRILOGY was a randomised, parallel group, double-blind, active-controlled study done in 159 sites across 14 countries...
September 3, 2016: Lancet
https://www.readbyqxmd.com/read/27452453/triple-inhaled-therapy-for-chronic-obstructive-pulmonary-disease
#14
REVIEW
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...
November 2016: Drug Discovery Today
https://www.readbyqxmd.com/read/27340255/high-dose-beclometasone-dipropionate-formoterol-fumarate-in-fixed-dose-combination-for-the-treatment-of-asthma
#15
REVIEW
Massimo Corradi, Monica Spinola, Stefano Petruzzelli, Piotr Kuna
The high-strength formulation of extrafine beclometasone dipropionate/formoterol fumarate (BDP/Form) 200/6 µg has been developed to step up inhaled corticosteroid treatment, without increasing the dose of the bronchodilator, in patients who are not controlled with previous therapies. Two clinical studies have evaluated efficacy of high-strength BDP/Form as compared with another high-dose fixed combination and BDP monotherapy. Overall, data show that BDP/Form 200/6 μg improves lung function and has beneficial effects on symptoms, use of rescue medication and asthma control, with an acceptable safety profile comparable with that of high-dose fluticasone propionate/salmeterol...
October 2016: Therapeutic Advances in Respiratory Disease
https://www.readbyqxmd.com/read/27309985/extrafine-beclometasone-diproprionate-formoterol-fumarate-a-review-of-its-effects-in-chronic-obstructive-pulmonary-disease
#16
REVIEW
Dave Singh, Massimo Corradi, Monica Spinola, Stefano Petruzzelli, Alberto Papi
A fixed-dose inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combination of extrafine beclometasone dipropionate and formoterol fumarate (BDP/FF) has been recently approved for use in chronic obstructive pulmonary disease (COPD). Small airway inflammation and remodelling are cardinal features of COPD; therefore, the ability of this extrafine formulation to reach the small, as well as the large, airways is likely to be therapeutically important by enabling treatment of inflammatory processes in the whole bronchial tree...
June 16, 2016: NPJ Primary Care Respiratory Medicine
https://www.readbyqxmd.com/read/27265314/comparison-of-the-cohesion-adhesion-balance-approach-to-colloidal-probe-atomic-force-microscopy-and-the-measurement-of-hansen-partial-solubility-parameters-by-inverse-gas-chromatography-for-the-prediction-of-dry-powder-inhalation-performance
#17
COMPARATIVE STUDY
Matthew D Jones, Graham Buckton
The abilities of the cohesive-adhesive balance approach to atomic force microscopy (AFM) and the measurement of Hansen partial solubility parameters by inverse gas chromatography (IGC) to predict the performance of carrier-based dry powder inhaler (DPI) formulations were compared. Five model drugs (beclometasone dipropionate, budesonide, salbutamol sulphate, terbutaline sulphate and triamcinolone acetonide) and three model carriers (erythritol, α-lactose monohydrate and d-mannitol) were chosen, giving fifteen drug-carrier combinations...
July 25, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27209586/a-two-period-open-label-single-dose-crossover-study-in-healthy-volunteers-to-evaluate-the-drug-drug-interaction-between-cimetidine-and-inhaled-extrafine-chf-5993
#18
RANDOMIZED CONTROLLED TRIAL
Fabrizia Mariotti, Giorgia Ciurlia, Luca Spaccapelo, Annamaria Muraro, Daniela Acerbi
BACKGROUND AND OBJECTIVES: CHF 5993 is an extrafine 'triple therapy' combination of the long-acting muscarinic antagonist glycopyrronium bromide (GB), the long-acting β2-agonist formoterol fumarate (FF), and the inhaled corticosteroid beclometasone dipropionate (BDP). It is in development for chronic obstructive pulmonary disease and asthma delivered via pressurised metered-dose inhaler. METHODS: This two-period, open-label, crossover study examined the drug-drug interaction of CHF 5993 and cimetidine...
April 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/27155173/access-to-essential-medicines-to-treat-chronic-respiratory-disease-in-low-income-countries
#19
K Bissell, C Perrin, D Beran
Chronic respiratory diseases (CRDs) affect hundreds of millions of people. The United Nations 2011 meeting on non-communicable diseases (NCDs) marked a turning point in addressing this burden. The targets established following this meeting incorporated specific measures to address the availability and affordability of essential medicines. These are aligned with the sustainable development goals (SDGs) and the push for universal health coverage. However, essential medicines for CRDs remain unaffordable and unavailable to many...
June 2016: International Journal of Tuberculosis and Lung Disease
https://www.readbyqxmd.com/read/27152404/asthma-a-summary-of-first-choice-treatments
#20
(no author information available yet)
First identify and avoid factors that trigger or aggravate asthma attacks First-line treatment for asthma is inhaled salbutamol: used on demand to relieve respiratory discomfort or to prevent attacks due to a known trigger; or on a daily basis if necessary, in combination with an inhaled corticosteroid such as beclometasone, for patients with persistent asthma. Treatment of severe persistent asthma is based on daily use of a high-dose inhaled corticosteroid, or possibly an oral corticosteroid, for as short a period as possible...
March 2016: Prescrire International
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