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Technical performance

Explore the technical performance of inhalers

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Particle size

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Inspiratory flow

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Carbon footprint of inhalers

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Technical performance: Summary

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Inhalers: Technical performance

Many factors affect the dose delivery from an inhaler:1-6

image-indicating-the-many-factors-that-can-affect-dose-delivery-and-lung-deposition-including-device-characteristics,-airway-anatomy-and-physiology,-and-inhalation-manoeuvre

Particle size

Aerodynamic particle size and delivery to the lung

Aerodynamic particle size may affect delivery of particles to the lung;7

  • particles >5µm are likely to be deposited in the oropharynx
  • particles <5µm are likely to be deposited beyond the upper airway in the bronchial/conducting airways or alveolar region
illustration-of-aerodynamic-particle-size-in-relation-to-the-lungs

Figure created independently by GSK.

  Median (range) MMAD (μm)8
FF
 3.9 (3.7–4.3)
UMEC
 3.1 (2.9–3.4)
VI 2.2 (1.9–2.5)

Particle size does not influence treatment effect

Different formulations of TIO resulted in a decreased dose with no difference in safety or efficacy.9

forest-plot-showing-results-from-a-meta-analysis-of-the-effect-on-FEV1-of-tiotropium-18-µg-delivered-via-DPI-versus-5-µg-delivered-via-SMI.-Different-formulations-of-tiotropium-resulted-in-a-decreased-dose-with-no-difference-in-safety-or-efficacy

Adapted from Calverley PM, Könen-Bergmann M, Richard F, et al. Tiotropium Respimat Versus HandiHaler : Comparison of Bronchodilator Efficacy of Various Doses in Clinical Trials. Adv Ther. 2016;33:786-793 under a Creative Commons License (https://creativecommons.org/licenses/by/4.0).

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Inspiratory flow

Most patients with COPD can achieve the PIFR required to use the Ellipta DPI

Two replicate randomised, phase IV, 12-week studies evaluated FF/UMEC/VI delivered via Ellipta DPI compared with BUD/FOR+TIO in patients with COPD.10

PIFR as assessed by spirometry (PIFRspirometry) was used to generate a predicted PIFR through the Ellipta DPI (PIFREllipta).10

*Spirometric PIF 50 L/min, estimated to be equivalent to an ELLIPTA PIF of ≥30 L/min; †spirometric PIF 102 L/min, which was the recorded spirometric value in the patient with the lowest recorded ELLIPTA PIF (43.5 L/min) in the RES113817/RES117178 studies (two-strip configuration). Estimation of ELLIPTA PIF is based on the equation derived from the RES113817/RES117178 studies, where estimations of below 43.5 L/min are based on extrapolation from spirometric PIF values below the observed minimum of 83.4 L/min. Extrapolating to 50 L/min spirometric PIF, there is 95% confidence that 90% of the population has at least 30 L/min ELLIPTA PIF (lower tolerance bound). Kaiser Permanente Northwest is a group-model, managed care organization, which provides care to approximately 600,000 insured members in northwest Oregon and southwest Washington, USA.

In vitro testing: Ellipta inhaler demonstrated consistent dose delivery across various inspiratory flow profiles*

Study evaluating in vitro dose delivery performance of FF/UMEC/VI delivered via Ellipta using the Electronic Lung, to replicate inhalation profiles of patients with COPD.11

*Delivered dose and fine particle dose determined as delivered from Ellipta using a bespoke Inhalation Profile Recorder. The Inhalation Profile Recorder was used to replicate five representative pre-recorded inhalation profiles encompassing the full range of PIFRs achieved by patients of all COPD severities in the study.

For each component delivered dose and fine particle dose were largely independent of PIFR across range of COPD severities.11

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At 43.5 L/min, >90% of the target dose of the component molecule was delivered.11

scatter-plot-showing-the-delivered-dose-and-fine-particle-dose-for-fluticasone-furoate-were-largely-independent-of-PIFR.-At-43.5-litres-per-minute,-more-than-90-percent-of-the-target-dose-of-the-component-molecule-was-delivered

FF, UMEV and VI licensed in combination (FF/VI, UMEC/VI, FF/UMEC/VI) for the treatment of COPD. Adapted with permission from Prime D, Hamilton M, Taylor E. In-vitro product performance of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) delivered from a dry powder inhaler (DPI) using the Electronic Lung (EL) to replicate patient inhalation profiles. Eur Respir J. 2019;54:PA4230.

At 43.5 L/min, >85% of the target dose of the component molecule was delivered.11

scatter-plot-showing-the-delivered-dose-and-fine-particle-dose-for-umeclidinium-were-largely-independent-of-PIFR.-At-43.5-litres-per-minute,-more-than-85-percent-of-the-target-dose-of-the-component-molecule-was-delivered

FF, UMEV and VI licensed in combination (FF/VI, UMEC/VI, FF/UMEC/VI) for the treatment of COPD. Adapted with permission from Prime D, Hamilton M, Taylor E. In-vitro product performance of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) delivered from a dry powder inhaler (DPI) using the Electronic Lung (EL) to replicate patient inhalation profiles. European Respir J. 2019;54:PA4230.

At 43.5 L/min, >80% of the target dose of the component molecule was delivered.11

scatter-plot-showing-the-delivered-dose-and-fine-particle-dose-for-vilanterol-were-largely-independent-of-PIFR.-At-43.5-litres-per-minute,-more-than-80-percent-of-the-target-dose-of-the-component-molecule-was-delivered

FF, UMEV and VI licensed in combination (FF/VI, UMEC/VI, FF/UMEC/VI) for the treatment of COPD. Adapted with permission from Prime D, Hamilton M, Taylor E. In-vitro product performance of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) delivered from a dry powder inhaler (DPI) using the Electronic Lung (EL) to replicate patient inhalation profiles. European Respir J. 2019;54:PA4230.

In vitro testing: Ellipta inhaler has consistent dose delivery down to a 30 L/min flow rate

In vitro, the ELLIPTA inhaler delivered a consistent dose, close to the stated label claim delivered dose, at flow rates between 30 and 90 L/min.5

bar-graph-showing-the-in-vitro-dose-delivery-of-the-Ellipta-inhaler-by-flow-rate.-For-fluticasone-furoate-mean-percent-nominal-blister-content-/-actuation-was-88-percent,-94-percent,-and-97-percent-for-flow-rates-of-30,-60,-and-90-litres-per-minutes-respectively. For-vilanterol-mean-percent-nominal-blister-content-/-actuation-was-80-percent,-90-percent,-and-90-percent-for-flow-rates-of-30,-60,-and-90-litres-per-minutes-respectively

*FF delivered as FF/VI 100/25 μg; †VI delivered as UMEC/VI 62.5/25 μg, FF/VI 100/25 μg or as FF/VI 200/25 μg, except at 60 L/min (delivered as FF/VI 100/25 μg).

There is no apparent relationship between spirometric PIFR and percent predicted FEV1 at screening

Post hoc analysis of two replicate randomised, Phase IV, 12-week studies (N=1951).10

scatter-plot-showing-the-relationship-between-spirometric-PIF-and-post-bronchodilator-percent-predicted-FEV1-at-screening-in-two-replicate-randomised-phase-four-12-week-studies.-There-was-no-relationship-observed-between-spirometric-PIF-at-screening-and-post-bronchodilator-percent-predicted-FEV1-in-patients-treated-with-either-FF/UMEC/VI-or-BUD/FOR-+-TIO

Adapted with permission from Anderson M, Collison K, Drummond MB, et al. Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data. Int J Chron Obstruct Pulmon Dis. 2021;16:933-943.

PIFR does not correlate with treatment efficacy on lung function outcomes

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In a post hoc analysis of two replicate randomised, phase IV, 12-week studies (N=1460 [ITT population]) no relationship was seen between patients’ PIFR values at screening and lung function outcomes at Week 12.10

scatter-plot-showing-the-relationship-between-spirometric-PIF-and-change-from-baseline-in-weighted-mean-FEV1-at-week-12-by-PIFR-at-screening-in-two-replicate-randomised-phase-four-12-week-studies.-There-was-no-relationship-observed-between-spirometric-PIF-at-screening-and- change-from-baseline-in-weighted-mean-FEV1-in-patients-treated-with-either-FF/UMEC/VI-or-BUD/FOR-+-TIO

Adapted with permission from Anderson M, Collison K, Drummond MB, et al. Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data. Int J Chron Obstruct Pulmon Dis. 2021;16:933-943.

In a post hoc analysis of two replicate randomised, phase IV, 12-week studies (N=1460 [ITT population]) no relationship was seen between patients’ PIFR values at screening and lung function outcomes at Week 12.10

scatter-plot-showing- the-relationship-between-spirometric-PIF-and change-from-baseline-in-trough-FEV1-at-week-12-by-PIFR-at-screening-in-two-replicate-randomised-phase-four-12-week-studies.-There-was-no-relationship-between-spirometric-PIF-at-screening-and-change-from-baseline-in-trough-FEV1-in-patients-treated-with-either-FF/UMEC/VI-or-BUD/FOR-+-TIO

Adapted with permission from Anderson M, Collison K, Drummond MB, et al. Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data. Int J Chron Obstruct Pulmon Dis. 2021;16:933-943.

No interaction between treatment and spirometry PIFR at screening was seen for any of the lung function endpoints in two replicate randomised, phase IV, 12-week studies.10

Week 12 lung function endpoint p-value for interaction of treatment with PIFR at screening
Weighted mean FEV1 (0–24 hours)
 0.415
Trough FEV1 0.091
12-hour FEV1 0.162
Trough FEV1 Week 12 to baseline ratio 0.275

Adapted with permission from Anderson M, Collison K, Drummond MB, et al. Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data. Int J Chron Obstruct Pulmon Dis. 2021;16:933-943.

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Carbon footprint

As a DPI, Ellipta does not contain a propellant so the carbon footprint is lower than for other types of inhaler.12 The carbon footprint of DPIs such as Ellipta can be as much as 25 times smaller than equivalent dosing with Evohaler MDIs (17 kg vs 439 kg eCO2 per annum).13

image-showing-that-the-carbon-footprint-of-DPIs-can-be-around-17-kilogram-of-carbon-dioxide-equivalents-per-annum-versus-439-kilogram-of-carbon-dioxide-equivalents-per-annum-for-MDIs
bar-graph-comparing-estimated-carbon-footprints.-The-carbon-footprint-of-two-puffs-of-a-pMDI-or-BAI-is-estimated-to-be-500-carbon-dioxide-equivalents.-The-carbon-footprint-of-1-dose-of-a-DPI-is-estimated-to-be-20-carbon-dioxide-equivalents

Adapted with permission from NICE, Patient decision aid: Inhalers for asthma, 2019. Available from: https://www.nice.org.uk/guidance/ng80/resources/inhalers-for-asthma-patient-decision-aid-pdf-6727144573. Accessed March 2022.

image-showing-the-header-for-a-BBC-news-article-from-October-2019

“And at the individual level, each metered-dose inhaler replaced by a dry powder inhaler could save the equivalent of between 150kg and 400kg (63 stone) of carbon dioxide a year – similar to the carbon footprint reduction of cutting meat from your diet.” BBC News, October 2019.14

Image reproduced with permission from https://www.bbc.co.uk/news/health-50215011

CO2 analysis of a monthly inhaled therapy

Carbon footprint for Ellipta compared with Evohaler.13

Carbon footprint (net kg of CO2/per pack annually) and annual carbon footprints of each device
  FF/VI Ellipta 92/22 µg
 SAL/FP Evohaler 25/250 µg
Production of active ingredients
 0.02
 0.08
Manufacturing
 0.73
 2.12
Distribution
 0.03
 0.03
Use
 0.00
 10.68
Disposal
 0.03
 6.08
Total CO2 per pack (kg)
 0.80
 19.0
Total CO2 per inhaler annually (kg)
 9.5
 234.0

Adapted with permission from Janson C, Henderson R, Löfdahl M, et al. Carbon footprint impact of the choice of inhalers for asthma and COPD. Thorax. 2020;75:82-84.

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Technical performance: Summary

  • Many factors affect inhaler dose delivery and lung deposition.1-4
  • Aerodynamic particle size must be appropriate in order to ensure correct delivery of particles to the lung.7
  • To ensure adequate dose delivery patients must be able to generate sufficient inspiratory flow based on the internal inhaler resistance.10,15
  • Most patients can achieve the minimum inspiratory flow needed for dose delivery when using the Ellipta inhaler.10,11

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Abbreviations

BAI, breath-actuated metered dose inhaler; BUD, budesonide; COPD, chronic obstructive pulmonary disease; DPI, dry powder inhaler; FEV1, forced expiratory volume in 1 second; FF, fluticasone furoate; FOR, formoterol; FP, fluticasone propionate; ITT, intent-to-treat; KPNW, Kaiser Permanente North West; MDI, metered dose inhaler; MMAD, mass median aerodynamic diameter; PIF, peak inspiratory flow; PIFR, peak inspiratory flow rate; pMDI, pressurised metered-dose inhaler; SAL, salmeterol; SMI, soft mist inhaler; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.

Ellipta and Evohaler are owned by or licensed to the GSK Group of Companies. HandiHaler and Respimat are registered trademarks of Boehringer Ingelheim International GmbH.

References

  1. Fernández Tena A, Casan Clarà P. Arch Bronconeumol. 2012;48:240-246.
  2. Rogliani P, Calzetta L, Coppola A, et al. Respir Med. 2017;124:6-14.
  3. Lavorini F, Magnan A, Dubus JC, et al. Respir Med. 2008;102:593-604.
  4. Kleinstreuer C, Zhang Z, Donohue JF. Annu Rev Biomed Eng. 2008;10:195-220.
  5. Grant AC, Walker R, Hamilton M, Garrill K. J Aerosol Med Pulm Drug Deliv. 2015;28:474-485.
  6. Hamilton M, Leggett R, Pang C, Charles S, Gillett B, Prime D. J Aerosol Med Pulm Drug Deliv. 2015;28:498-506.
  7. Laube BL, Janssens HM, de Jongh FH, et al. Eur Respir J. 2011;37:1308-1331.
  8. GSK. GSK data on file 2017N335327_00. Accessed March 2022.
  9. Calverley PM, Könen-Bergmann M, Richard F, Bell S, Hohlfeld JM. Adv Ther. 2016;33:786-793.
  10. Anderson M, Collison K, Drummond MB, et al. Int J Chron Obstruct Pulmon Dis. 2021;16:933-943.
  11. Prime D, Hamilton M, Taylor E. European Respiratory Journal. 2019;54:PA4230.
  12. NICE. Patient decision aid. Inhalers for asthma. Information to help people with asthma and their healthcare professionals discuss their options for inhaler devices. Available at: https://www.nice.org.uk/guidance/ng80/resources/inhalers-for-asthma-patient-decision-aid-pdf-6727144573 Accessed March 2022.
  13. Janson C, Henderson R, Löfdahl M, Hedberg M, Sharma R, Wilkinson AJK. Thorax. 2020;75:82-84.
  14. BBC News. Asthma carbon footprint 'as big as eating meat'. 30 October 2019; Available at: https://www.bbc.co.uk/news/health-50215011 Accessed March 2022.
  15. GOLD. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2022. Available at: https://goldcopd.org/2022-gold-reports-2/ Accessed March 2022.

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

NX-GBL-UCV-WCNT-220004 | Date of preparation: August 2022