605
Views
13
CrossRef citations to date
0
Altmetric
Review

Consistent Pulmonary Drug Delivery with Whole Lung Deposition Using the Aerosphere Inhaler: A Review of the Evidence

ORCID Icon, ORCID Icon, , ORCID Icon, &
Pages 113-124 | Published online: 18 Jan 2021

References

  • Global Initiative for Chronic Obstructive Lung Disease. 2020 report: global strategy for the diagnosis, management and prevention of COPD. 2020. Available from: https://goldcopd.org/gold-reports/. Accessed March 17, 2020.
  • Global Initiative for Asthma. 2019 Report: global strategy for asthma management and prevention. 2019. Available from: https://ginasthma.org/. Accessed December 17, 2019.
  • Usmani OS. Choosing the right inhaler for your asthma or COPD patient. Ther Clin Risk Manag. 2019;15(14):461–472. doi:10.2147/TCRM.S160365
  • Melani AS, Bonavia M, Cilenti V, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011;105(6):930–938. doi:10.1016/j.rmed.2011.01.005
  • Sanchis J, Gich I, Pedersen S. Systematic review of errors in inhaler use: has patient technique improved over time? Chest. 2016;150(2):394–406. doi:10.1016/j.chest.2016.03.041
  • Lavorini F, Usmani OS. Correct inhalation technique is critical in achieving good asthma control. Prim Care Respir J. 2013;22(4):385–386. doi:10.4104/pcrj.2013.00097
  • Usmani OS, Lavorini F, Marshall J, et al. Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes. Respir Res. 2018;19(1):10. doi:10.1186/s12931-017-0710-y
  • Chrystyn H, van der Palen J, Sharma R, et al. Device errors in asthma and COPD: systematic literature review and meta-analysis. NPJ Prim Care Respir Med. 2017;27(1):22. doi:10.1038/s41533-017-0016-z
  • Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002;19(2):246–251. doi:10.1183/09031936.02.00218402
  • Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of β2-agonist particle size. Am J Respir Crit Care Med. 2005;172(12):1497–1504. doi:10.1164/rccm.200410-1414OC
  • Van Holsbeke C, De Backer J, Vos W, Marshall J. Use of functional respiratory imaging to characterize the effect of inhalation profile and particle size on lung deposition of inhaled corticosteroid/long-acting β2-agonists delivered via a pressurized metered-dose inhaler. Ther Adv Respir Dis. 2018;12:1753466618760948. doi:10.1177/1753466618760948
  • Darquenne C. Aerosol deposition in health and disease. J Aerosol Med Pulm Drug Deliv. 2012;25(3):140–147. doi:10.1089/jamp.2011.0916
  • Verbanck S, Biddiscombe MF, Usmani OS. Inhaled aerosol dose distribution between proximal bronchi and lung periphery. Eur J Pharm Biopharmaceutics. 2020;152:18–22. doi:10.1016/j.ejpb.2020.04.019
  • Ding B, Kallenbach L, Slipski L, Wilk A, O’Brien D, Guranlioglu D. Demographics and clinical characteristics of patients with COPD utilizing LAMA/LABA fixed-dose combination therapy: a U.S. database study. Thorax. 2018;73(Suppl 4):A233–A233. doi:10.1136/thorax-2018-212555.399
  • Stein SW, Sheth P, Hodson PD, Myrdal PB. Advances in metered dose inhaler technology: hardware development. AAPS PharmSciTech. 2014;15(2):326–338. doi:10.1208/s12249-013-0062-y
  • Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005;50(9):1177–1190.
  • Myrdal PB, Sheth P, Stein SW. Advances in metered dose inhaler technology: formulation development. AAPS PharmSciTech. 2014;15(2):434–455. doi:10.1208/s12249-013-0063-x
  • Lechuga-Ballesteros D, Noga B, Vehring R, Cummings RH, Dwivedi SK. Novel cosuspension metered-dose inhalers for the combination therapy of chronic obstructive pulmonary disease and asthma. Future Med Chem. 2011;3(13):1703–1718. doi:10.4155/fmc.11.133
  • Michael Y, Snowden MJ, Chowdhry BZ, Ashurst IC, Davies-Cutting CJ, Riley T. Characterisation of the aggregation behaviour in a salmeterol and fluticasone propionate inhalation aerosol system. Int J Pharm. 2001;19(221(1–2)):165–174. doi:10.1016/S0378-5173(01)00678-0
  • Vehring R, Lechuga-Ballesteros D, Joshi V, Noga B, Dwivedi SK. Cosuspensions of microcrystals and engineered microparticles for uniform and efficient delivery of respiratory therapeutics from pressurized metered dose inhalers. Langmuir. 2012;28(42):15015–15023. doi:10.1021/la302281n
  • Wauthoz N, Amighi K. Phospholipids in pulmonary drug delivery. Eur J Lipid Sci Technol. 2014;116(9):1114–1128. doi:10.1002/ejlt.201300368
  • AstraZeneca Pharmaceuticals LP. Bevespi Aerosphere™ Prescribing Information. 2019. Available from: http://www.azpicentral.com/bevespi/bevespi_pi.pdf. Accessed July 2, 2019.
  • AstraZeneca Pharmaceuticals LP. Breztri Aerosphere™ Prescribing Information. 2020. Available from: https://www.azpicentral.com/breztri/breztri.pdf. Accessed November 13, 2020.
  • AstraZeneca AB. Bevespi Aerosphere summary of product characteristics. 2018. Available from: https://www.ema.europa.eu/en/documents/product-information/bevespi-aerosphere-epar-product-information_en.pdf. Accessed June 13, 2019.
  • European Medicines Agency. CHMP summary of positive opinion for Trixeo Aerosphere. 2020. Available from: https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-trixeo-aerosphere_en.pdf. Accessed November 13, 2020.
  • AstraZeneca. Bevespi Aerosphere approved by the Japanese Ministry of Health, Labour and Welfare for patients with chronic obstructive pulmonary disease. 2019. Available from: https://www.astrazeneca.com/media-centre/press-releases/2019/bevespi-aerosphere-approved-by-the-japanese-ministry-of-health-labour-and-welfare-for-patients-with-chronic-obstructive-pulmonary-disease-19062019.html. Accessed 2 July 2019.
  • AstraZeneca. Breztri Aerosphere (PT010) approved in Japan for patients with chronic obstructive pulmonary disease. 2019. Available from: https://www.astrazeneca.com/media-centre/press-releases/2019/breztri-aerosphere-pt010-approved-in-japan-for-patients-with-chronic-obstructive-pulmonary-disease-19062019.html. Accessed July 2, 2019.
  • AstraZeneca. Bevespi Aerosphere approved in China for patients with COPD. 2020. Available from: https://www.astrazeneca.com/media-centre/press-releases/2020/bevespi-aerosphere-approved-in-china-for-patients-with-copd.html. Accessed July 7, 2020.
  • AstraZeneca. AstraZeneca’s triple-combination therapy approved in China for patients with COPD. 2019. Available from: https://www.astrazeneca.com/media-centre/press-releases/2019/astrazenecas-triple-combination-therapy-approved-in-china-for-patients-with-copd-23122019.html. Accessed December 23, 2019.
  • Martinez FJ, Rabe KF, Ferguson GT, et al. Efficacy and safety of glycopyrrolate/formoterol metered dose inhaler formulated using co-suspension delivery technology in patients with COPD. Chest. 2017;151(2):340–357. doi:10.1016/j.chest.2016.11.028
  • Lipworth BJ, Collier DJ, Gon Y, et al. Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized phase III study conducted in Asia, Europe, and the USA. Int J Chron Obstruct Pulmon Dis. 2018;13:2969–2984. doi:10.2147/COPD.S171835
  • Hanania NA, Tashkin DP, Kerwin EM, et al. Long-term safety and efficacy of glycopyrrolate/formoterol metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with chronic obstructive pulmonary disease. Respir Med. 2017;126:105–115. doi:10.1016/j.rmed.2017.03.015
  • Ferguson GT, Rabe KF, Martinez FJ, et al. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, Phase 3 randomised controlled trial. Lancet Respir Med. 2018;6(10):747–758. doi:10.1016/S2213-2600(18)30327-8
  • Martinez FJ, Fabbri LM, Ferguson GT, et al. Baseline symptom score impact on benefits of glycopyrrolate/formoterol metered dose inhaler in COPD. Chest. 2017;152(6):1169–1178. doi:10.1016/j.chest.2017.07.007
  • Doty A, Schroeder J, Vang K, et al. Drug delivery from an innovative LAMA/LABA co-suspension delivery technology fixed-dose combination MDI: evidence of consistency, robustness, and reliability. AAPS PharmSciTech. 2018;19(2):837–844. doi:10.1208/s12249-017-0891-1
  • Sheth P, Archbell J, Miller K, Wu L, Vang K, Mack P. Drug delivery from a novel fixed-dose ICS/LAMA/LABA MDI using co-suspension delivery technology: evidence of consistency, robustness, and reliability. Poster presented at: American Association of Pharmaceutical Scientists Pharmsci 360; 4 November 2019; San Antonio, Texas, USA. Available from: https://shwca.se/pharmsci2019. Accessed January 7, 2021.
  • Hamilton M, Leggett R, Pang C, Charles S, Gillett B, Prime D. In vitro dosing performance of the ELLIPTA® dry powder inhaler using asthma and COPD patient inhalation profiles replicated with the electronic lung (eLung). J Aerosol Med Pulm Drug Deliv. 2015;28(6):498–506. doi:10.1089/jamp.2015.1225
  • De Maria R, Zagnoni I, Bodria A, et al. Foster®: a high-efficiency combination metered dose inhaler with consistent particle size distribution at alternative flow rates. Combination Prod Ther. 2014;4(1):1–5. doi:10.1007/s13556-013-0006-6
  • Johal B, Howald M, Fischer M, Marshall J, Venthoye G. Fine particle profile of fluticasone propionate/formoterol fumarate versus other combination products: the DIFFUSE study. Combination Prod Ther. 2013;3(1):39–51. doi:10.1007/s13556-013-0003-9
  • Wu L, Van Holsbeke C, Mack P. Consistent lung delivery of inhaled triple ICS/LAMA/LABA combination using the co-suspension delivery technology: an in silico modelling study. Poster presented at: American Association of Pharmaceutical Scientists Pharmsci 360; 5 November 2019; San Antonio, Texas, USA. Available from: https://shwca.se/pharmsci2019. Accessed January 7, 2021.
  • Hatley RH, Parker J, Pritchard JN, von Hollen D. Variability in delivered dose from pressurized metered-dose inhaler formulations due to a delay between shake and fire. J Aerosol Med Pulm Drug Deliv. 2017;30(1):71–79. doi:10.1089/jamp.2015.1284
  • Thorsson L, Edsbäcker S. Lung deposition of budesonide from a pressurized metered-dose inhaler attached to a spacer. Eur Respir J. 1998;12(6):1340–1345. doi:10.1183/09031936.98.12061340
  • Chrystyn H. Methods to identify drug deposition in the lungs following inhalation. Br J Clin Pharmacol. 2001;51(4):289–299. doi:10.1046/j.1365-2125.2001.01304.x
  • Vos W, de Backer J, Schroeder J, Sommerville M, Dwivedi S, De Backer W. In-silico assessment of airway deposition using functional respiratory imaging for mono, dual and triple combination co-suspension metered dose inhaler formulations. Am J Respir Crit Care Med. 2016;193:A5811.
  • Hajian B, De Backer J, Vos W, Van Holsbeke C, Clukers J, De Backer W. Functional respiratory imaging (FRI) for optimizing therapy development and patient care. Expert Rev Respir Med. 2016;10(2):193–206. doi:10.1586/17476348.2016.1136216
  • Taylor G, Warren S, Dwivedi S, et al. Gamma scintigraphic pulmonary deposition study of glycopyrronium/formoterol metered dose inhaler formulated using co-suspension delivery technology. Eur J Pharm Sci. 2018;111:450–457. doi:10.1016/j.ejps.2017.10.026
  • Israel S, Kumar A, DeAngelis K, et al. Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects. Eur J Pharm Sci. 2020;2020(153):105472.
  • Darquenne C, Fleming JS, Katz I, et al. Bridging the gap between science and clinical efficacy: physiology, imaging, and modeling of aerosols in the lung. J Aerosol Med Pulm Drug Deliv. 2016;29(2):107–126. doi:10.1089/jamp.2015.1270
  • Chrystyn H. Methods to determine lung distribution of inhaled drugs - could gamma scintigraphy be the gold standard? Br J Clin Pharmacol. 2000;49(6):525–528. doi:10.1046/j.1365-2125.2000.00215.x
  • Newman S, Bennett WD, Biddiscombe M, et al. Standardization of techniques for using planar (2D) imaging for aerosol deposition assessment of orally inhaled products. J Aerosol Med Pulm Drug Deliv. 2012;25(Suppl. 1):S10–S28. doi:10.1089/jamp.2012.1Su4
  • Brand P, Hederer B, Austen G, Dewberry H, Meyer T. Higher lung deposition with Respimat Soft Mist inhaler than HFA-MDI in COPD patients with poor technique. Int J Chron Obstruct Pulmon Dis. 2008;3(4):763–770. doi:10.2147/COPD.S3930
  • De Backer W, Devolder A, Poli G, et al. Lung deposition of BDP/formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD patients. J Aerosol Med Pulm Drug Deliv. 2010;23(3):137–148. doi:10.1089/jamp.2009.0772
  • Hirst PH, Pitcairn GR, Weers JG, et al. In vivo lung deposition of hollow porous particles from a pressurized metered dose inhaler. Pharm Res. 2002;19(3):258–264. doi:10.1023/A:1014482615914
  • Leach CL, Kuehl PJ, Chand R, McDonald JD. Respiratory tract deposition of HFA-beclomethasone and HFA-fluticasone in asthmatic patients. J Aerosol Med Pulm Drug Deliv. 2016;29(2):127–133. doi:10.1089/jamp.2014.1199
  • Leach CL, Kuehl PJ, Chand R, Ketai L, Norenberg JP, McDonald JD. Characterization of respiratory deposition of fluticasone-salmeterol hydrofluoroalkane-134a and hydrofluoroalkane-134a beclomethasone in asthmatic patients. Ann Allergy Asthma Immunol. 2012;108(3):195–200. doi:10.1016/j.anai.2012.01.010
  • De Backer W, De Backer J, Vos W, et al. A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018;13:2673–2684. doi:10.2147/COPD.S171707
  • Rabe KF. GFF MDI for the improvement of lung function in COPD – a look at the PINNACLE-1 and PINNACLE-2 data and beyond. Expert Rev Clin Pharm. 2017;10(7):685–698. doi:10.1080/17512433.2017.13202180
  • De Backer J, Vos W, Vinchurkar S, et al. The effects of extrafine beclometasone/formoterol (BDP/F) on lung function, dyspnea, hyperinflation, and airway geometry in COPD patients: novel insight using functional respiratory imaging. J Aerosol Med Pulm Drug Deliv. 2015;28(2):88–99. doi:10.1089/jamp.2013.1064
  • De Backer LA, Vos W, De Backer J, Van Holsbeke C, Vinchurkar S, De Backer W. The acute effect of budesonide/formoterol in COPD: a multi-slice computed tomography and lung function study. Eur Respir J. 2012;40(2):298–305. doi:10.1183/09031936.00072511
  • De Backer LA, Vos WG, Salgado R, et al. Functional imaging using computer methods to compare the effect of salbutamol and ipratropium bromide in patient-specific airway models of COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:637–646. doi:10.2147/COPD.S21917
  • DeBacker W, DeBacker J, Verlinden I, et al. Functional respiratory imaging assessment of glycopyrrolate and formoterol fumarate metered dose inhalers formulated using co-suspension delivery technology in patients with COPD. Ther Adv Respir Dis. 2020;14:1–13. doi:10.1177/1753466620916990
  • Usmani OS, Capstick T, Chowhan H, Scullion J Choosing an appropriate inhaler device for the treatment of adults with asthma or COPD. 2017. Available from: https://www.guidelines.co.uk/respiratory/inhaler-choice-guideline/252870.article. Accessed November 19, 2018.
  • Price D, Chrystyn H, Kaplan A, et al. Effectiveness of same versus mixed asthma inhaler devices: a retrospective observational study in primary care. Allergy Asthma Immunol Res. 2012;4(4):184–191. doi:10.4168/aair.2012.4.4.184
  • Bosnic-Anticevich S, Chrystyn H, Costello RW, et al. The use of multiple respiratory inhalers requiring different inhalation techniques has an adverse effect on COPD outcomes. Int J Chron Obstruct Pulmon Dis. 2016;12:59–71. doi:10.2147/COPD.S117196
  • Lavorini F, Fontana GA. Targeting drugs to the airways: the role of spacer devices. Expert Opin Drug Deliv. 2009;6(1):91–102. doi:10.1517/17425240802637862
  • Mahler DA. Peak inspiratory flow rate as a criterion for dry powder inhaler use in chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2017;14(7):1103–1107. doi:10.1513/AnnalsATS.201702-156PS
  • Janssens W, VandenBrande P, Hardeman E, et al. Inspiratory flow rates at different levels of resistance in elderly COPD patients. Eur Respir J. 2008;31(1):78–83. doi:10.1183/09031936.00024807
  • Hakim A, Khan Y, Esteban I, et al. Low-dose budesonide/formoterol counteracts airway inflammation and improves lung function in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2019;199(5):662–664. doi:10.1164/rccm.201808-1590LE
  • Pleasants RA, Hess DR. Aerosol delivery devices for obstructive lung diseases. Respir Care. 2018;63(6):708–733. doi:10.4187/respcare.06290
  • ClinicalTrials.gov. A study to evaluate the effects of BGF and GFF on specific image based airway volumes and resistance in subjects with moderate to severe COPD. 2019. Available from: https://clinicaltrials.gov/ct2/show/NCT03836677. Accessed May 22, 2019.
  • ClinicalTrials.gov. A scintigraphy study of PT010 in COPD patients (RD708/34000). 2019. Available from: https://clinicaltrials.gov/ct2/show/study/NCT03906045. Accessed May 22, 2019.
  • Vincken W, Levy ML, Scullion J, Usmani OS, Dekhuijzen PNR, Corrigan CJ. Spacer devices for inhaled therapy: why use them, and how? ERJ Open Res. 2018;4(2):00065–02018. doi:10.1183/23120541.00065-2018
  • ClinicalTrials.gov. A study to assess the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) in adults and children 4 years of age or older with asthma (MANDALA). 2018. Available from: https://clinicaltrials.gov/ct2/show/NCT03769090. Accessed May 21, 2019.
  • ClinicalTrials.gov. A study to assess the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) used 4 times daily in adults and children 4 years of age or older with asthma (DENALI). 2019. Available from: https://clinicaltrials.gov/ct2/show/NCT03847896. Accessed May 21, 2019.
  • Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461–464. doi:10.7326/M15-0288