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Unmet need

In this section the symptom burden and unmet needs of patients with COPD are discussed, as well as the importance of correct inhaler technique and the impact of multiple inhaler therapy.

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Global burden on COPD

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Guidelines emphasise the role of correct inhaler technique for COPD and asthma

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Use of multiple, different inhaler types can add to treatment complexity

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Key features of commonly used inhalers

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Unmet need: Summary

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Global burden of COPD1

image-showing-that-globally-3-million-deaths-occur-due-to-COPD-per-year.-This-equates-to-over-6-percent-of-global-deaths,-making-COPD-the-third-leading-cause-of-death-worldwide

  • Dyspnoea is the most common COPD symptom and has a considerable impact on daily life.2-4

    Dyspnoea is the most common COPD symptom and has a considerable impact on daily life.2-4

    A cross-sectional, observational study in 17 countries (N= 2441) identified the daily activities that patients felt were most affected by COPD symptoms.3

    Proportion of patients with daily activities most affected by COPD symptoms

    image-showing-the-proportion-of-patients-with-daily-activities-most-affected-by-COPD-symptoms.-82.5-percent-of-patients-found-going-up-and-down-stairs-was-affected,-56.9-percent-found-heavy-household-duties-affected,-43.1-percent-found-going-shopping-was-affected,-and-35.9-percent-found-doing-sports-or-hobbies-was-affected

  • High symptom burden and exacerbations are key contributors to the burden of COPD5

    Three-year all-cause mortality in patients with COPD by GOLD 2017 subgroup stratified by symptoms and exacerbation risk showed all-cause mortality increased with increasing exacerbations and dyspnoea.5

    line-graph-showing-all-cause-mortality-over-3-years-in-patients-with-COPD-by-GOLD-2017-subgroup-stratified-by-symptoms-and-exacerbation-risk.-At-3-years-all-cause-cumulative-mortality-was-8.9-percent-for-GOLD-Group-A,-15.5-percent-for-GOLD-Group-C,-23.2-percent-for-GOLD-Group-B,-and-35.3-percent-for-GOLD-Group-D

    Adapted with permission from Gedebjerg A, Szépligeti SK, Wackerhausen LH, et al. Prediction of mortality in patients with chronic obstructive pulmonary disease with the new Global Initiative for Chronic Obstructive Lung Disease 2017 classification: a cohort study. Lancet Respir Med. 2018;6:204-212.

    Therapy icon

    Inhaled maintenance therapy is a cornerstone of COPD treatment2

    Inhaler icon

    Choice of inhaler device and appropriate inhaler technique are important considerations to improve outcomes in patients with COPD2

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Guidelines emphasise the role of correct inhaler technique for COPD and asthma

Organisation Recommendation 
GOLD (2022)
 There is a significant relationship between poor inhaler technique and symptom control in patients with COPD; therefore, inhaler technique needs to be assessed regularly.2
GINA (2021)
 If a patient is not controlled, first check their inhaler technique.6

  • Poor inhalation technique results in worsening outcomes

    Poor inhalation technique results in worsening outcomes

    An observational study (N=1664) into the prevalence of inhaler mishandling in patients with respiratory disease found that in patients with asthma (42%) and COPD (52%), using an MDI (n=843) or DPI (n=1113), mishandling was common and associated with poor clinical control and increased healthcare resource utilisation.7

    bar-graph-showing-the-percentage-of-observations-of-inhaler-technique-according-to-some-unscheduled-health-care-resources-use-in-the-last-year.-In-patients-with-asthma-and-COPD-using-an-MDI-or-DPI-mishandling-was-common-and-associated-with-poor-clinical-control-and-increased-healthcare-resource-utilisation-including-hospital-admission,-emergency-visit,-antibiotic-course,-and-oral-corticosteriod-use

  • Inhaler errors are common in patients with COPD in routine clinical practice8

    Inhaler errors are common in patients with COPD in routine clinical practice8

    On average, more than two-thirds of patients make at least one error when using an inhalational device.2 In a study to evaluate inhaler handling in a real-word setting (N=2935), regardless of inhaler device, <40% of patients were able to perform an inhalation without errors according to the inhaler leaflet.8

    bar-graph-showing-the-proportion-of-patients-with-COPD-making-an-inhaler-handling-error-with-6-different-inhaler-devices.-Regardless-of-inhaler-device,-less-than-40-percent-of-patients-were-able-to-perform-an-inhalation-without-errors

    Device independent errors included: no exhalation before inhalation, inspiration through the nose or not holding the breath a few seconds after inhalation. Other errors were considered device dependent. Critical errors were those that could substantially affect dose delivery to the lungs: Breezhaler, failure to insert capsule, failure to press and release buttons, powder remaining in the capsule by the end of inhalation; Diskus, failure to slide the lever, manoeuvre despite no dose remaining on the dose counter; HandiHaler, opening the next dose blister, failure to insert capsule, failure to press and release buttons, powder remaining in the capsule by the end of inhalation; pMDI, poorly synchronised hand actuation and inhalation; Respimat, lack of cartridge in the device, manoeuvre despite no dose remaining on the dose counter, failure twisting the base, poorly synchronised hand actuation and inhalation; Turbuhaler, failure to hold the inhaler upright when twisting the grip (tolerance ±45°), missing rotating grip clockwise then anticlockwise until ‘click’, manoeuvre despite no dose remaining on the dose counter.

  • Inhaler errors are associated with more patients having COPD exacerbations

    Inhaler errors are associated with more patients having COPD exacerbations

    In a study to evaluate inhaler handling in a real-world setting (N=2935), a higher proportion of patients with moderate/severe† or severe‡ exacerbations had ≥1 critical error than no error.8

    Errors were considered critical if they could have substantially affected dose delivery to the lungs.8

    *Devices: Breezhaler, Diskus, HandiHaler, pMDI, Respimat, Turbuhaler; †Requiring antibiotherapy, corticotherapy or ER visit/hospitalisation; ‡ER visit or hospitalisation.8

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Use of multiple, different inhaler types can add to treatment complexity

“The importance of education and training in inhaler device technique cannot be over-emphasised” (GOLD 2021).2

image-showing-different-ICS/LABA-and-LAMA-inhaler-devices-available-and-how-they-can-be-combined

Figure created independently by GSK.

One of the determinants of poor inhaler technique is the use of multiple devices.2

A study of adult patients with asthma (N=321) looked at the proportion of patients making no inhalation errors based on whether patients were using one or multiple inhalers.9

bar-graph-showing-the-proportion-of-patients-with-asthma-making-no-inhalation-errors-based-on-the-number-of-inhalers-used.-71-percent-of-patients-did-not-make-an-inhalation-error-when-using-one-inhaler,-and-61-percent-of-patients-made-no-errors-when-using-2-or-more-inhalers

The inhalers used included MDI, Autohaler (3M Healthcare), Cyclohaler (Pharmachemie), Diskhaler (GlaxoSmithKline), Inhaler Ingelheim (Boehringer Ingelheim), Rotahaler (Boehringer Ingelheim), Turbuhaler (AstraZeneca).

Use of mixed inhaler types, requiring different techniques, is associated with worsening outcomes in patients with COPD

In a database study of patients with COPD (N=8225 in each of the two cohorts; similar-device and mixed-devices), patients using multiple devices with similar inhalation techniques had better clinical outcomes compared with patients using devices that required mixed inhalation technique.10

Patients using multiple inhalers that require similar inhalation techniques had a lower rate of moderate/severe exacerbations and were less likely to require a higher SABA dose versus patients using inhalers requiring mixed techniques during the outcome year.10

  IRR/OR for similar device cohort vs mixed device cohort (95% CI)
Moderate–severe exacerbations (IRR)
 0.82 (0.80, 0.84)
Average daily SABA dose (OR)
 0.54 (0.51, 0.57)

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Key features of commonly used inhalers

  Ellipta
GlaxoSmithKline
 Aerosphere
AstraZeneca/Pearl
Therapeutics
 Respimat*
Boehringer Ingelheim		 NEXThaler11
Chiesi
Delivery device
 DPI12
 pMDI using
‘Co-suspension
Technology’13,14
 SMI12 pMDI11
Dosing
 1 inhalation QD15
 2 inhalations BID10 2 inhalations QD16 2 inhalations BID11
Molecules FF/UMEC/VI11 GLY/FOR10 TIO/OLO12 BDP/GLY/FOR11
Inhalation time At least 3–4 seconds17 Up to 10 seconds12 10 seconds12 4–5 seconds11
Particle size (MMAD)† FF, 3.9 μm19
UMEC, 3.1 μm19
VI, 2.2 μm19		 <6.4 μm20 3.7 μm21 1.1 μm11
Dosing indicator Moves after every dose22 Moves after every 10 puffs13 Increments of 30 doses23 Moves after every puff (60 or 120 puff container) or in increments of 20 (180 puff container)11
Resistance (PIF) Medium/low (30 L/min)22 – – –
Error rate‡ 10%24 60%24¶
45.6% (95% CI: 26.0, 66.6)25§		 100%26 60%24¶
45.6% (95% CI: 26.0, 66.6)25§
Teaching time, min 3.7924 6.3024 – –
Patient preference 75% (n=80)24 19% (n=80)24‡ 72% vs pMDI
(n=224)27
64% vs Diskus
(n=150)27		 19% (n=80)24‡

Note: As there are no head-to-head clinical trials comparing these characteristics, direct comparisons between the devices cannot be made and no conclusions must be made regarding any differences presented.

*Data are for the previous disposable Respimat inhaler; †particles with an MMAD between 2 and 6 μm are best suited for deposition in the central and small airways;28 ‡patients with at least one critical error, defined as an error likely to result in the inhalation of significantly reduced, minimal or no medication; data are for MDIs in general – no studies have been conducted with the Aerosphere MDI or Tribow MDI; §n=10 studies. Trademarks are the property of their respective owners.

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Unmet need: Summary

  • Inhaler errors are common in clinical practice and guidelines emphasise the importance of correct inhaler technique.2,17
  • One of the determinants of poor inhaler technique is the use of multiple inhaler types.2,7
  • Poor inhaler technique can lead to worsening outcomes.7

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Technical performance

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Patient benefits

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Abbreviations

BDP, beclometasone dipropionate; BID, twice a day; CI, confidence interval; COPD, chronic obstructive pulmonary disease; DPI, dry powder inhaler; ER, emergency room; FF, fluticasone furoate; FOR, formoterol; GINA, Global Initiative for Asthma; GLY, glycopyrrolate; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; IRR, incidence rate ratio; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; MDI, metered dose inhaler; MMAD, mass median aerodynamic diameter; mMRC, Modified Medical Research Council; OLO, olodaterol; PIF, peak inspiratory flow; pMDI, pressurised metered dose inhaler; QD, once a day; SABA, short-acting β2-agonist; SMI, soft mist inhaler; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.

Ellipta, Accuhaler, Diskhaler, Diskus and Rotahaler are owned by or licensed to the GSK Group of Companies. HandiHaler, Respimat and Inhaler Ingelheim are registered trademarks of Boehringer Ingelheim International GmbH. Turbuhaler and Genuair are registered trademarks of AstraZeneca. Spiromax is a registered trademark of IVAX International B.V. Breezhaler is a registered trademark of Novartis AG. Fostair and NEXThaler are registered trademarks of Chiesi Farmaceutici S.P.A. Autohaler is a registered trademark of 3M Company. Cyclohaler is a registered trademark of Pharmachemie B.V.

References

  1. World Health Organization. The top 10 causes of death. 2018. Available at: www.who.int/en/news-room/fact-sheets/detail/the-top-10-causes-of-death Accessed December 2021.
  2. GOLD. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2022. Available at: https://goldcopd.org/2022-gold-reports/ Accessed December 2021.
  3. Kessler R, Partridge MR, Miravitlles M, et al. Eur Respir J. 2011;37:264-272.
  4. Punekar YS, Mullerova H, Small M, et al. Pulmonary Therapy. 2016;2:59-72.
  5. Gedebjerg A, Szépligeti SK, Wackerhausen LH, et al. Lancet Respir Med. 2018;6:204-212.
  6. GINA. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention 2021. Available at: https://ginasthma.org/gina-reports/ Accessed August 2021.
  7. Melani AS, Bonavia M, Cilenti V, et al. Respir Med. 2011;105:930-938.
  8. Molimard M, Raherison C, Lignot S, et al. Eur Respir J. 2017;49:1601794.
  9. van der Palen J, Klein JJ, van Herwaarden CL, Zielhuis GA, Seydel ER. Eur Respir J. 1999;14:1034-1037.
  10. Bosnic-Anticevich S, Chrystyn H, Costello RW, et al. Int J Chron Obstruct Pulmon Dis. 2017;12:59-71.
  11. Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution - Summary of Product Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/documents/product-information/trimbow-epar-product-information_en.pdf Accessed November 2021
  12. Alcázar Navarrete B, Boucot I, Naya I, et al. Pulm Ther. 2018;4:171-183.
  13. Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension - Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/12024/smpc/print Accessed August 2021
  14. Bevespi Aerosphere, US Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208294s000lbl.pdf Accessed October 2021
  15. Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed - Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/8666/smpc/print Accessed August 2021.
  16. Spiriva Respimat 2.5 microgram, inhalation solution - Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/407/smpc/print Accessed August 2021.
  17. Package leaflet: Information for the patient, Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed. Available at: https://www.medicines.org.uk/emc/files/pil.8666.pdf Accessed October 2021.
  18. Package leaflet: Information for the user, Bevespi Aerosphere® 7.2 micrograms / 5 micrograms pressurised inhalation, suspension. Available at: https://www.medicines.org.uk/emc/files/pil.12024.pdf Accessed November 2021.
  19. GSK. GSK data on file 2017N335327_00. Accessed August 2021.
  20. Usmani OS, Roche N, Jenkins M, Stjepanovic N, Mack P, De Backer W. Int J Chron Obstruct Pulmon Dis. 2021;16:113-124.
  21. Ciciliani AM, Langguth P, Wachtel H. Int J Chron Obstruct Pulmon Dis. 2017;12:1565-1577.
  22. Grant AC, Walker R, Hamilton M, Garrill K. J Aerosol Med Pulm Drug Deliv. 2015;28:474-485.
  23. Anderson P. Int J Chron Obstruct Pulmon Dis. 2006;1:251-259.
  24. van der Palen J, Thomas M, Chrystyn H, et al. NPJ Prim Care Respir Med. 2016;26:16079.
  25. Chrystyn H, van der Palen J, Sharma R, et al. NPJ Prim Care Respir Med. 2017;27:22.
  26. Ding B, Siddiqui S, DePietro M, Petersson G, Martin UJ. Chron Respir Dis. 2019;16:1479972318787914.
  27. Hodder R, Price D. Int J Chron Obstruct Pulmon Dis. 2009;4:381-390.
  28. Darquenne C. J Aerosol Med Pulm Drug Deliv. 2012;25:140-147.

© 2022 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies.

NX-GBL-UCV-WCNT-220003 | Date of preparation: August 2022