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STUDY PROTOCOL

BDP/FF NEXThaler to Improve Asthma Control Status in the Real World: The NEWTON Study

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Pages 1177-1186 | Received 26 Jun 2023, Accepted 18 Sep 2023, Published online: 25 Oct 2023

References

  • Oladunni E, Sumita S. The global impact of asthma in adult populations. Ann Glob Health. 2019;85(1):2. doi:10.5334/aogh.2412
  • Global Initiative for Asthma. Global strategy for asthma management and prevention, 2023. Available from: www.ginasthma.org. Accessed August 6, 2023.
  • Nunes C, Pereira AM, Morais-Almeida M. Asthma costs and social impact. Asthma Res Pract. 2017;3(1):1. doi:10.1186/s40733-016-0029-3
  • Juniper EF, O’Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999;14(4):902–907. doi:10.1034/j.1399-3003.1999.14d29.x
  • Nathan RA, Sorkness CA, Kosinski M, et al. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113(1):59–65. doi:10.1016/j.jaci.2003.09.008
  • Ducharme FM, Ni Chroinin M, Greenstone I, Lasserson TJ. Addition of long-acting beta2-agonists to inhaled steroids versus higher dose inhaled steroids in adults and children with persistent asthma. Cochrane Database Syst Rev. 2010;2010(4):CD005533.
  • Papi A, Corradi M, Pigeon-Francisco C, et al. Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. Lancet Respir Med. 2013;1(1):23–31. doi:10.1016/S2213-2600(13)70012-2
  • Huchon G, Magnussen H, Chuchalin A, Dymek L, Gonod FB, Bousquet J. Lung function and asthma control with beclomethasone and formoterol in a single inhaler. Respir Med. 2009;103(1):41–49. doi:10.1016/j.rmed.2008.09.002
  • Allegra L, Cremonesi G, Girbino G, et al. for PRISMA (PRospectIve Study on asthMA control) Study Group, Real-life prospective study on asthma control in Italy: cross-sectional phase results. Respir Med. 2012;106(2):205–2014. doi:10.1016/j.rmed.2011.10.001
  • Müller V, Gálffy G, Eszes N, et al. Asthma control in patients receiving inhaled corticosteroid and long-acting beta2-agonist fixed combinations. A real-life study comparing dry powder inhalers and a pressurized metered dose inhaler extra-fine formulation. BMC Pulm Med. 2011;11(1):40. doi:10.1186/1471-2466-11-40
  • Papi A. Inhaled BDP/formoterol extra-fine combination. Evidence and future perspectives. Pneumologie. 2009;63(Suppl 2):S102–106. doi:10.1055/s-0029-1214716
  • Virchow JC, Poli G, Herpich C, et al. Lung deposition of the dry powder fixed combination beclometasone dipropionate plus formoterol fumarate using NEXThaler® device in healthy subjects, asthmatic patients, and COPD patients. J Aerosol Med Pulm Drug Deliv. 2018;31(5):269–280. doi:10.1089/jamp.2016.1359
  • Watz H, Barile S, Guastalla D, et al. Targeting the small airways with inhaled corticosteroid/long-acting beta agonist dry powder inhalers: a functional respiratory imaging study. J Aerosol Med Pulm Drug Deliv. 2021;34(5):280–292. doi:10.1089/jamp.2020.1618
  • Chetta A, Facciolongo N, Franco C, Franzini L, Piraino A, Rossi C. Impulse oscillometry, small airways disease, and extra-fine formulations in asthma and chronic obstructive pulmonary disease: windows for new opportunities. Ther Clin Risk Manag. 2022;18:965–979. doi:10.2147/TCRM.S369876
  • Emeryk A, Janeczek K. Feedback systems in multi-dose dry powder inhalers. Postepy Dermatol Alergol. 2023;40(1):16–21. doi:10.5114/ada.2022.117039
  • Corradi M, Chrystyn H, Cosio BG, et al. NEXThaler, an innovative dry powder inhaler delivering an extrafine fixed combination of beclometasone and formoterol to treat large and small airways in asthma. Expert Opin Drug Deliv. 2014;11(9):1497–1506. doi:10.1517/17425247.2014.928282
  • Chetta A, Yorgancioglu A, Scuri M, Barile S, Guastalla D, Dekhuijzen PNR. Inspiratory flow profile and usability of the NEXThaler, a multidose dry powder inhaler, in asthma and COPD. BMC Pulm Med. 2021;21(1):65. doi:10.1186/s12890-021-01430-9
  • Singh D, van den Berg F, Leaker B, et al. Comparison of the effect of beclometasone/formoterol in asthma patients after methacholine-induced bronchoconstriction: a noninferiority study using metered dose vs. dry powder inhaler. Br J Clin Pharmacol. 2019;85(4):729–736. doi:10.1111/bcp.13847
  • Kanniess F, Scuri M, Vezzoli S, Francisco C, Petruzzelli S. Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler(®)) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: a randomised, double-blind trial. Pulm Pharmacol Ther. 2015;30:121–127. doi:10.1016/j.pupt.2014.07.006
  • Ruessel K, Luecke E, Schreiber J. Inhaler devices in a geriatric patient population: a prospective cross-sectional study on patient preferences. Patient Prefer Adherence. 2020;14:1811–1822. doi:10.2147/PPA.S262057
  • Voshaar T, Spinola M, Linnane P, et al. Comparing usability of NEXThaler(®) with other inhaled corticosteroid/long-acting β2-agonist fixed combination dry powder inhalers in asthma patients. J Aerosol Med Pulm Drug Deliv. 2014;27(5):363–370. doi:10.1089/jamp.2013.1086
  • Schreiber J, Sonnenburg T, Luecke E. Inhaler devices in asthma and COPD patients - A prospective cross-sectional study on inhaler preferences and error rates. BMC Pulm Med. 2020;20(1):222. doi:10.1186/s12890-020-01246-z
  • Varacca G, D’Angelo D, Glieca S, et al. The impact of possible improper use on the performance in vitro of NEXThaler in comparison with Ellipta inhaler. Eur J Pharm Sci. 2023;183:106385. doi:10.1016/j.ejps.2023.106385
  • Farkas Á, Tomisa G, Kugler S, et al. The effect of exhalation before the inhalation of dry powder aerosol drugs on the breathing parameters, emitted doses and aerosol size distributions. Int J Pharm X. 2023;5:100167. doi:10.1016/j.ijpx.2023.100167
  • Cloutier MM, Dixon AE, Krishnan JA, Lemanske RF, Pace W, Schatz M. Managing asthma in adolescents and adults: 2020 asthma guideline update from the national asthma education and prevention program. JAMA. 2020;324(22):2301–2317. doi:10.1001/jama.2020.21974
  • National Institute for Health and Care Excellence (NICE)Asthma: Diagnosis, Monitoring and Chronic Asthma Management. London: National Institute for Health and Care Excellence (NICE); 2021.
  • Sobieraj DM, Weeda ER, Nguyen E, et al. Association of inhaled corticosteroids and long-acting β-agonists as controller and quick relief therapy with exacerbations and symptom control in persistent asthma: a systematic review and meta-analysis. JAMA. 2018;319(14):1485–1496. doi:10.1001/jama.2018.2769
  • Di Marco F. Today’s improvement in asthma treatment: role of MART and Easyhaler. Multidiscip Respir Med. 2020;15(1):649. doi:10.4081/mrm.2020.649
  • Wilkinson A, Woodcock A. The environmental impact of inhalers for asthma: a green challenge and a golden opportunity. Br J Clin Pharmacol. 2022;88(7):3016–3022. doi:10.1111/bcp.15135
  • Bateman ED, Boushey HA, Bousquet J, et al. for GOAL Investigators Group, Can guideline-defined asthma control be achieved? The gaining optimal asthma control study. Am J Respir Crit Care Med. 2004;170(8):836–844. doi:10.1164/rccm.200401-033OC
  • García-Marcos L, Chiang CY, Asher MI, et al. Asthma management and control in children, adolescents, and adults in 25 countries: a global asthma network Phase I cross-sectional study. Lancet Glob Health. 2023;11(2):e218–e228. doi:10.1016/S2214-109X(22)00506-X
  • Bakakos P, Chatziapostolou P, Katerelos P, Efstathopoulos P, Korkontzelou A, Katsaounou P. 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. J Pers Med. 2022;12(2):146. doi:10.3390/jpm12020146
  • Ulmeanu R, Bloju S, Vittos O. Assessment of symptoms control, pulmonary function and related quality of life in asthmatic patients treated with extrafine beclomethasone dipropionate/formoterol fumarate 100/6 μg pMDI: results of a multicenter observational study in Romania (ALFRESCO Study). J Asthma Allergy. 2022;15:919–933. doi:10.2147/JAA.S358798
  • Hodzhev VA, Kenderov AN, Ivanov YY, Gospodinova-Vulkova DP, Kalinov K. Assessment of extrafine beclomethasone/formoterol for the treatment of chronic obstructive pulmonary disease: a non-interventional study in a Bulgarian population. Pulm Pharmacol Ther. 2022;77:102169. doi:10.1016/j.pupt.2022.102169
  • Chiesi Italia. Effects of beclometasone dipropionate/formoterol fumarate via NEXT(Haler) in a real-world study on asthma control (NEWTON); Available from: https://www.clinicaltrials.gov/ct2/show/NCT05168995NLMidentifier:NCT05168995. Accessed May 14, 2023.
  • Terzano C, Cremonesi G, Girbino G, et al. PRISMA (PRospectIve Study on asthMA control) Study Group, 1-year prospective real-life monitoring of asthma control and quality of life in Italy. Respir Res. 2012;13(1):112. doi:10.1186/1465-9921-13-112
  • Manap RA, Loh LC, Ismail TS, et al. Satisfaction levels and asthma control amongst Malaysian asthmatic patients on budesonide/formoterol maintenance and reliever therapy: experience in a real-life setting. Patient Relat Outcome Meas. 2012;3:71–78. doi:10.2147/PROM.S19211
  • Dixon WJ, Massey J. Introduction to Statistical Analysis. 4th ed. New York: McGraw-Hill; 1983:385–414.
  • Braido F, Scichilone N, Lavorini F, et al. 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) [published correction appears in world allergy organ J. 2022;15(2):100596]. World Allergy Organ J. 2016;9(1):37. doi:10.1186/s40413-016-0123-2