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NEXThaler, an innovative dry powder inhaler delivering an extrafine fixed combination of beclometasone and formoterol to treat large and small airways in asthma

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Jinping Zheng, Jianyong Zhang, Xiuhua Fu, Changqing Lin, Xinri Zhang, Xiaodong Mei, Massimo Corradi, Glauco Cappellini, Emanuele Calabro, Cissy Zhu & Eva Topole. (2023) Comparison of extrafine beclomethasone dipropionate/formoterol fumarate dry powder inhaler and pressurized metered-dose inhaler in Chinese patients with asthma: the FORTUNE study. Journal of Asthma 0:0, pages 1-8.
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Anne Haaije de Boer, Paul Hagedoorn & Floris Grasmeijer. (2022) Dry powder inhalation, part 2: the present and future. Expert Opinion on Drug Delivery 19:9, pages 1045-1059.
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Piotr Damiański, Grzegorz Kardas, Michał Panek, Piotr Kuna & Maciej Kupczyk. (2022) Improving the risk-to-benefit ratio of inhaled corticosteroids through delivery and dose: current progress and future directions. Expert Opinion on Drug Safety 21:4, pages 499-515.
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Kai-Michael Beeh, Piotr Kuna, Massimo Corradi, Isabelle Viaud, Alessandro Guasconi & George Georges. (2021) Comparison of Dry-Powder Inhaler and Pressurized Metered-Dose Inhaler Formulations of Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium in Patients with COPD: The TRI-D Randomized Controlled Trial. International Journal of Chronic Obstructive Pulmonary Disease 16, pages 79-89.
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Mario Cazzola, Francesco Cavalli, Omar S. Usmani & Paola Rogliani. (2020) Advances in pulmonary drug delivery devices for the treatment of chronic obstructive pulmonary disease. Expert Opinion on Drug Delivery 17:5, pages 635-646.
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A. H. de Boer, P. Hagedoorn, M. Hoppentocht, F. Buttini, F. Grasmeijer & H. W. Frijlink. (2017) Dry powder inhalation: past, present and future. Expert Opinion on Drug Delivery 14:4, pages 499-512.
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Michal Pirozynski & Tomasz R. Sosnowski. (2016) Inhalation devices: from basic science to practical use, innovative vs generic products. Expert Opinion on Drug Delivery 13:11, pages 1559-1571.
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Ernesto Crisafulli, Andrea Zanini, Giovanna Pisi, Patrizia Pignatti, Gianluigi Poli, Mario Scuri & Alfredo Chetta. (2016) Inhaled beclometasone dipropionate/formoterol fumarate extrafine fixed combination for the treatment of asthma. Expert Review of Respiratory Medicine 10:5, pages 481-490.
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Andrea S. Melani & Davide Paleari. (2016) Maintaining Control of Chronic Obstructive Airway Disease: Adherence to Inhaled Therapy and Risks and Benefits of Switching Devices. COPD: Journal of Chronic Obstructive Pulmonary Disease 13:2, pages 241-250.
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Articles from other publishers (64)

Árpád Farkas, Gábor Tomisa, Szilvia Kugler, Attila Nagy, Attila Vaskó, Erika Kis, Georgina Szénási, Gabriella Gálffy & Alpár Horváth. (2023) The effect of exhalation before the inhalation of dry powder aerosol drugs on the breathing parameters, emitted doses and aerosol size distributions. International Journal of Pharmaceutics: X 5, pages 100167.
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Fulvio Braido, Enrico Arnaboldi, Sara Barile, Luca Cavalieri, Eleonora Ingrassia, Maria Russo & Alessio Piraino. (2023) BDP/FF NEXThaler to Improve Asthma Control Status in the Real World: The NEWTON Study. Journal of Asthma and Allergy Volume 16, pages 1177-1186.
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Heba Banat, Rita Ambrus & Ildikó Csóka. (2023) Drug combinations for inhalation: Current products and future development addressing disease control and patient compliance. International Journal of Pharmaceutics 643, pages 123070.
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Giada Varacca, Davide D'Angelo, Stefania Glieca, Luca Cavalieri, Alessio Piraino, Eride Quarta, Fabio Sonvico & Francesca Buttini. (2023) The impact of possible improper use on the performance in vitro of NEXThaler in comparison with Ellipta inhaler. European Journal of Pharmaceutical Sciences 183, pages 106385.
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Davide D'Angelo, Veronica Chierici, Eride Quarta, Giada Varacca, Luca Cavalieri, Alessio Piraino, Andrea S. Melani, Fabio Sonvico & Francesca Buttini. (2023) No-shaking and shake-fire delays affect respirable dose for suspension but not solution pMDIs. International Journal of Pharmaceutics 631, pages 122478.
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Anne de Boer, Paul Hagedoorn & Floris Grasmeijer. 2023. Practical Pharmaceutics. Practical Pharmaceutics 299 335 .
Vladimir A. Hodzhev, Andrey N. Kenderov, Yavor Y. Ivanov, Diana P. Gospodinova-Vulkova & Krasimir Kalinov. (2022) Assessment of extrafine beclomethasone/formoterol for the treatment of chronic obstructive pulmonary disease: A non-interventional study in a Bulgarian population. Pulmonary Pharmacology & Therapeutics 77, pages 102169.
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Árpád Farkas, Alpár Horváth, Gábor Tomisa, Tamás Kovács, Renáta Marietta Böcskei, Erika Kis & János Varga. (2022) Do we really target the receptors? Deposition and co-deposition of ICS-LABA fixed combination drugs. European Journal of Pharmaceutical Sciences 174, pages 106186.
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Didier Cataldo, Shane Hanon, Rudi V. Peché, Daniel J. Schuermans, Jean M. Degryse, Isabelle A. De Wulf, Karin Elinck, Mathias H. Leys, Peter L. Rummens & Eric Derom. (2022) How to Choose the Right Inhaler Using a Patient-Centric Approach?. Advances in Therapy 39:3, pages 1149-1163.
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Petros Bakakos, Panagiotis Chatziapostolou, Panos Katerelos, Petros Efstathopoulos, Aliki Korkontzelou & Paraskevi Katsaounou. (2022) Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma—The NEXT-Step Study. Journal of Personalized Medicine 12:2, pages 146.
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Omar S Usmani. 2022. Encyclopedia of Respiratory Medicine. Encyclopedia of Respiratory Medicine 754 765 .
Chandrakantsing V. Pardeshi, Sagar R. Pardeshi & Jitendra B. Naik. 2022. Advanced Drug Delivery Strategies for Targeting Chronic Inflammatory Lung Diseases. Advanced Drug Delivery Strategies for Targeting Chronic Inflammatory Lung Diseases 219 258 .
Hadeer S. Harb, Nabila Ibrahim Laz, Hoda Rabea, Yasmin M. Madney, Marian S. Boshra & Mohamed E. A. Abdelrahim. (2021) Aerosol drug‐delivery and short‐term clinical outcomes of suboptimal peak inspiratory flow rate in chronic obstructive pulmonary disease. International Journal of Clinical Practice 75:12.
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Francesca Orsola Alfano, Andrea Benassi, Roberto Gaspari, Alberto Di Renzo & Francesco Paolo Di Maio. (2021) Full-Scale DEM Simulation of Coupled Fluid and Dry-Coated Particle Flow in Swirl-Based Dry Powder Inhalers. Industrial & Engineering Chemistry Research 60:42, pages 15310-15326.
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Ting Liu, Dan Yang & Chuntao Liu. (2021) Extrafine HFA-beclomethasone-formoterol vs. nonextrafine combination of an inhaled corticosteroid and a long acting β2-agonist in patients with persistent asthma: A systematic review and meta-analysis. PLOS ONE 16:9, pages e0257075.
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Henrik WatzSara BarileDaniele GuastallaEva TopoleDaniela CocconiBenjamin MignotDennis BelmansDildar DumanGianluigi PoliLeonardo M. Fabbri. (2021) Targeting the Small Airways with Inhaled Corticosteroid/Long-Acting Beta Agonist Dry Powder Inhalers: A Functional Respiratory Imaging Study. Journal of Aerosol Medicine and Pulmonary Drug Delivery 34:5, pages 280-292.
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Omar S. Usmani, Rajiv Dhand, Federico Lavorini & David Price. (2021) Why We Should Target Small Airways Disease in Our Management of Chronic Obstructive Pulmonary Disease. Mayo Clinic Proceedings 96:9, pages 2448-2463.
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R. Ponzini, R. Da Vià, S. Bnà, C. Cottini & A. Benassi. (2021) Coupled CFD-DEM model for dry powder inhalers simulation: Validation and sensitivity analysis for the main model parameters. Powder Technology 385, pages 199-226.
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Paola Rogliani, Beatrice Ludovica Ritondo, Bartolomeo Zerillo, Maria Gabriella Matera & Luigino Calzetta. (2021) Drug interaction and chronic obstructive respiratory disorders. Current Research in Pharmacology and Drug Discovery 2, pages 100009.
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Debabrata Ghosh Dastidar, Dipanjan Ghosh, Swarnasree Ghosh & Gopal Chakrabarti. 2021. Targeting Cellular Signalling Pathways in Lung Diseases. Targeting Cellular Signalling Pathways in Lung Diseases 847 902 .
Alpár Horváth, Árpád Farkas, Annamária Szipőcs, Gábor Tomisa, Zsuzsanna Szalai & Gabriella Gálffy. (2020) Numerical simulation of the effect of inhalation parameters, gender, age and disease severity on the lung deposition of dry powder aerosol drugs emitted by Turbuhaler®, Breezhaler® and Genuair® in COPD patients. European Journal of Pharmaceutical Sciences 154, pages 105508.
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Albert Brau Tarrida, Silvia Álvarez Álvarez & Xavier Flor Escriche. (2020) Terapia SMART en asma. FMC - Formación Médica Continuada en Atención Primaria 27:6, pages 300-311.
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Tijana I. Šušteršič & Nenad Filipovic. 2020. Computational Modeling in Bioengineering and Bioinformatics. Computational Modeling in Bioengineering and Bioinformatics 257 288 .
Pran Kishore Deb, Sara Nidal Abed, Hussam Maher, Amal Al-Aboudi, Anant Paradkar, Shantanu Bandopadhyay & Rakesh K. Tekade. 2020. Drug Delivery Systems. Drug Delivery Systems 521 577 .
Árpád Farkas, Frantisek Lizal, Jan Jedelsky, Jakub Elcner, Alpár Horváth & Miroslav Jicha. (2019) Simulation of Airway Deposition of an Aerosol Drug in COPD Patients. Pharmaceutics 11:4, pages 153.
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Stewart Yeung, Daniela Traini, Alan Tweedie, David Lewis, Tanya Church & Paul M. Young. (2019) Assessing Aerosol Performance of a Dry Powder Carrier Formulation with Increasing Doses Using a Novel Inhaler. AAPS PharmSciTech 20:3.
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Dave Singh, Frans Berg, Brian Leaker, Massimo Corradi, Sunny Jabbal, Sara Collarini, Valentina Mongelli, Luigi Santoro, Annalisa Piccinno, Sonia Biondaro & Brian Lipworth. (2019) Comparison of the effect of beclometasone/formoterol in asthma patients after methacholine‐induced bronchoconstriction: A noninferiority study using metered dose vs . dry powder inhaler . British Journal of Clinical Pharmacology 85:4, pages 729-736.
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Jeffry G. WeersYoen-Ju SonMark GluskerAlfred HaynesDaniel HuangNani KadrichuJohn LeXue LiRichard MalcolmsonDanforth P. MillerThomas E. TararaKeith UngAndy Clark. (2019) Idealhalers Versus Realhalers: Is It Possible to Bypass Deposition in the Upper Respiratory Tract?. Journal of Aerosol Medicine and Pulmonary Drug Delivery 32:2, pages 55-69.
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Roberto W. Dal Negro, Luca Bonadiman & Paola Turco. (2018) Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/Formoterol 100/6 μg b.I.D.: a 12-month comparison of outcomes in mild-to-moderate asthma. Multidisciplinary Respiratory Medicine 13:1.
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Luigino Calzetta, Maria Gabriella Matera, Francesco Facciolo, Mario Cazzola & Paola Rogliani. (2018) Beclomethasone dipropionate and formoterol fumarate synergistically interact in hyperresponsive medium bronchi and small airways. Respiratory Research 19:1.
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Hong-Goo Lee, Dong-Wook Kim & Chung-Woong Park. (2017) Dry powder inhaler for pulmonary drug delivery: human respiratory system, approved products and therapeutic equivalence guideline. Journal of Pharmaceutical Investigation 48:6, pages 603-616.
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Johann Christian VirchowGianluigi PoliChristiane HerpichClaudius KietzigHilke EhlichDaniela BraeutigamKnut SommererSabine HäussermannFabrizia Mariotti. (2018) Lung Deposition of the Dry Powder Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Using NEXThaler ® Device in Healthy Subjects, Asthmatic Patients, and COPD Patients . Journal of Aerosol Medicine and Pulmonary Drug Delivery 31:5, pages 269-280.
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C. Merusi, G. Brambilla, E.J. Long, G.K. Hargrave & H.K. Versteeg. (2018) Optical diagnostics studies of air flow and powder fluidisation in Nexthaler®. Part II: Use of fluorescent imaging to characterise transient release of fines from a dry powder inhaler. International Journal of Pharmaceutics 549:1-2, pages 96-108.
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Martyn F. Biddiscombe & Omar S. Usmani. (2018) Is there room for further innovation in inhaled therapy for airways disease?. Breathe 14:3, pages 216-224.
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Stewart Yeung, Daniela Traini, David Lewis & Paul M. Young. (2018) Dosing challenges in respiratory therapies. International Journal of Pharmaceutics 548:1, pages 659-671.
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M.W. Jetzer, B.D. Morrical, M. Schneider, S. Edge & G. Imanidis. (2018) Probing the particulate microstructure of the aerodynamic particle size distribution of dry powder inhaler combination products. International Journal of Pharmaceutics 538:1-2, pages 30-39.
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Francesca Buttini, Stavroula Rozou, Alessandra Rossi, Varvara Zoumpliou & Dimitrios M. Rekkas. (2018) The application of Quality by Design framework in the pharmaceutical development of dry powder inhalers. European Journal of Pharmaceutical Sciences 113, pages 64-76.
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Sitaram P. Velaga, Jelena Djuris, Sandra Cvijic, Stavroula Rozou, Paola Russo, Gaia Colombo & Alessandra Rossi. (2018) Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products. European Journal of Pharmaceutical Sciences 113, pages 18-28.
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Sohini GhoshJill A. OharM. Bradley Drummond. (2017) Peak Inspiratory Flow Rate in Chronic Obstructive Pulmonary Disease: Implications for Dry Powder Inhalers. Journal of Aerosol Medicine and Pulmonary Drug Delivery 30:6, pages 381-387.
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Ayah Shakshuki & Remigius U. Agu. (2017) Improving the Efficiency of Respiratory Drug Delivery: A Review of Current Treatment Trends and Future Strategies for Asthma and Chronic Obstructive Pulmonary Disease. Pulmonary Therapy 3:2, pages 267-281.
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Árpád Farkas, David Lewis, Tanya Church, Alan Tweedie, Francesca Mason, Allen E. Haddrell, Jonathan P. Reid, Alpár Horváth & Imre Balásházy. (2017) Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler® dry powder inhaler. International Journal of Pharmaceutics 533:1, pages 225-235.
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Federico Lavorini, Søren Pedersen, Omar S. Usmani, P.J. Barnes, L. Corbetta, C.J. Corrigan, B.L. Chawes, P.N.R. Dekhuijzen, T. Hausen, F. Lavorini, M.L. Levy, S. Pedersen, N. Roche, J. Sanchis, O.S. Usmani & W. Vincken. (2017) Dilemmas, Confusion, and Misconceptions Related to Small Airways Directed Therapy. Chest 151:6, pages 1345-1355.
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Sohita Dhillon. (2017) Extrafine beclometasone dipropionate/formoterol fumarate metered-dose and dry-powder inhalers in asthma and chronic obstructive pulmonary disease: a profile of their use. Drugs & Therapy Perspectives 33:6, pages 260-271.
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Paola Rogliani, Luigino Calzetta, Angelo Coppola, Francesco Cavalli, Josuel Ora, Ermanno Puxeddu, Maria Gabriella Matera & Mario Cazzola. (2017) Optimizing drug delivery in COPD: The role of inhaler devices. Respiratory Medicine 124, pages 6-14.
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Jeffry Weers & Andy Clark. (2016) The Impact of Inspiratory Flow Rate on Drug Delivery to the Lungs with Dry Powder Inhalers. Pharmaceutical Research 34:3, pages 507-528.
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F. Braido, N. Scichilone, F. Lavorini, O. S. Usmani, L. Dubuske, L. P. Boulet, R. Mosges, C. Nunes, M. Sánchez-Borges, I. J. Ansotegui, M. Ebisawa, F. Levi-Schaffer, L. J Rosenwasser, J. Bousquet, T. Zuberbier & G. Walter Canonica. (2016) Manifesto on small airway involvement and management in asthma and chronic obstructive pulmonary disease: an Interasma (Global Asthma Association - GAA) and World Allergy Organization (WAO) document endorsed by Allergic Rhinitis and its Impact on Asthma (ARIA) and Global Allergy and Asthma European Network (GA2LEN). Asthma Research and Practice 2:1.
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Roberto W. Dal Negro, Chiara Distante, Luca Bonadiman, Paola Turco & Sergio Iannazzo. (2016) Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/ Formoterol 100/6 μg b.i.d.: a 12-week cost analysis in mild-to-moderate asthma. Multidisciplinary Respiratory Medicine 11:1.
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Francesca Buttini, James Hannon, Kristi Saavedra, Irene Rossi, Anna Giulia Balducci, Hugh Smyth, Andy Clark & Paolo Colombo. (2016) Accessorized DPI: a Shortcut towards Flexibility and Patient Adaptability in Dry Powder Inhalation. Pharmaceutical Research 33:12, pages 3012-3020.
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Árpád Farkas, Ágnes Jókay, Imre Balásházy, Péter Füri, Veronika Müller, Gábor Tomisa & Alpár Horváth. (2016) Numerical simulation of emitted particle characteristics and airway deposition distribution of Symbicort® Turbuhaler® dry powder fixed combination aerosol drug. European Journal of Pharmaceutical Sciences 93, pages 371-379.
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Peter Haidl, Stefan Heindl, Karsten Siemon, Maria Bernacka & Rolf Michael Cloes. (2016) Inhalation device requirements for patients' inhalation maneuvers. Respiratory Medicine 118, pages 65-75.
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V. V. Arkhipov, D. E. Arkhipova & N. B. Lazareva. (2016) Novel inhalation devices for treatment of chronic obstructive pulmonary disease. PULMONOLOGIYA 26:3, pages 352-356.
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Ágnes Jókay, Árpád Farkas, Péter Füri, Alpár Horváth, Gábor Tomisa & Imre Balásházy. (2016) Computer modeling of airway deposition distribution of Foster ® NEXThaler ® and Seretide ® Diskus ® dry powder combination drugs. European Journal of Pharmaceutical Sciences 88, pages 210-218.
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Francesca ButtiniGaetano BrambillaDiego CopelliViviana SistiAnna Giulia BalducciRuggero BettiniIrene Pasquali. (2016) Effect of Flow Rate on In Vitro Aerodynamic Performance of NEXThaler ® in Comparison with Diskus ® and Turbohaler ® Dry Powder Inhalers . Journal of Aerosol Medicine and Pulmonary Drug Delivery 29:2, pages 167-178.
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Francesca Buttini, Irene Pasquali, Gaetano Brambilla, Diego Copelli, Massimiliano Dagli Alberi, Anna Giulia Balducci, Ruggero Bettini & Viviana Sisti. (2015) Multivariate Analysis of Effects of Asthmatic Patient Respiratory Profiles on the In Vitro Performance of a Reservoir Multidose and a Capsule-Based Dry Powder Inhaler. Pharmaceutical Research 33:3, pages 701-715.
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F. Braido, N. Scichilone, F. Lavorini, O.S. Usmani, L. Dubuske, L.P. Boulet, R. Mosges, C. Nunes, M. Sanchez-Borges, I.J. Ansotegui, M. Ebisawa, F. Levi-Schaffer, L.J. Rosenwasser, J. Bousquet, T. Zuberbier & G. Walter Canonica. (2016) Manifesto on small airway involvement and management in asthma and chronic obstructive pulmonary disease: an Interasma (Global Asthma Association - GAA) and World Allergy Organization (WAO) document endorsed by Allergic Rhinitis and its Impact on Asthma (ARIA) and Global Allergy and Asthma European Network (GA2LEN). World Allergy Organization Journal 9, pages 37.
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Matteo Bonini & Omar S. Usmani. (2015) The importance of inhaler devices in the treatment of COPD. COPD Research and Practice 1:1.
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Matteo Bonini & Omar S. Usmani. (2015) The role of the small airways in the pathophysiology of asthma and chronic obstructive pulmonary disease. Therapeutic Advances in Respiratory Disease 9:6, pages 281-293.
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Anna Giulia Balducci, Hartwig Steckel, Francesco Guarneri, Alessandra Rossi, Gaia Colombo, Fabio Sonvico, Eike Cordts, Ruggero Bettini, Paolo Colombo & Francesca Buttini. (2015) High shear mixing of lactose and salmeterol xinafoate dry powder blends: Biopharmaceutic and aerodynamic performances. Journal of Drug Delivery Science and Technology 30, pages 443-449.
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I. Pasquali, C. Merusi, G. Brambilla, E.J. Long, G.K. Hargrave & H.K. Versteeg. (2015) Optical diagnostics study of air flow and powder fluidisation in Nexthaler ® —Part I: Studies with lactose placebo formulation. International Journal of Pharmaceutics 496:2, pages 780-791.
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Anne H. de Boer, Doetie Gjaltema, Paul Hagedoorn & Henderik W. Frijlink. (2015) Can ‘extrafine’ dry powder aerosols improve lung deposition?. European Journal of Pharmaceutics and Biopharmaceutics 96, pages 143-151.
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Nicola Scichilone, Alida Benfante, Marialuisa Bocchino, Fulvio Braido, Pierluigi Paggiaro, Alberto Papi, Pierachille Santus & Alessandro Sanduzzi. (2015) Which factors affect the choice of the inhaler in chronic obstructive respiratory diseases?. Pulmonary Pharmacology & Therapeutics 31, pages 63-67.
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Nicola Scichilone. (2015) Asthma Control: The Right Inhaler for the Right Patient. Advances in Therapy 32:4, pages 285-292.
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Beverley Bostock-Cox. (2015) Prescribing new therapies for the management of asthma. Nurse Prescribing 13:1, pages 18-22.
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Beverley Bostock-Cox. (2014) Role of new therapies in optimizing asthma care. Practice Nursing 25:12, pages 596-601.
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