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Ellipta critical error studies - COPD

Significantly fewer patients using Ellipta made critical errors compared with other commonly used inhalers, after reading the patient information leaflet. 1

A critical error is defined as inhaler usage likely to result in no, or minimal, medication being inhaled. The key results were:

  • 8 x fewer patients made critical errors with Ellipta compared to Accuhaler
  • 5 x fewer patients made critical errors with Ellipta compared to MDI
  • 3 x fewer patients made critical errors with Ellipta compared to Handihaler
Key results - comparison of Ellipta with 5 other COPD inhalers

MDI, metered dose inhaler

Ellipta, Accuhaler and the shape of the respective inhalers are registered trademarks of the GSK group of companies. Other trademarks referred to herein are the property of their respective owners.

    • All participants were receiving treatment and were naïve to using the Ellipta inhaler and at least one of the other five inhaler devices of comparison: Accuhaler, MDI, Turbohaler, HandiHaler and Breezhaler.
    • Participants received inactive treatment (placebo) via the Ellipta inhaler and one of the five other inhaler devices depending on the study to which they were allocated.
    • Patients were randomised to determine the sequence in which they demonstrated inhaler use.
    • At the study visit, participants were asked to demonstrate use of the inhaler after reading the patient information leaflet; any errors made were recorded by a study nurse using a specific checklist for each inhaler.
    • The primary endpoint was the percentage of participants making at least one critical error after reading the patient information leaflet.
  • Ellipta is the only once-daily inhaler that enables device continuity for patients with COPD. 234 More than 95% of patients used Ellipta correctly first time after initial demonstration. 5

     

     

  • Ellipta Accuhaler MDI (Placebo HFA – Suspension Formulation)
    • Failed to open cover
    • Shook the device upside down after dose preparation
    • Exhaled directly into mouthpiece
    • No seal by the lips round the mouthpiece during the inhalation



    • Failed to open cover
    • Lever is not pushed back
    • Shook the device after dose preparation
    • Exhaled directly into mouthpiece
    • No seal by the lips round the mouthpiece during inhalation


    • Failed to remove cap
    • Did not shake the device
    • Failed to place device in mouth
    • No dose actuated during an inhalation manoeuvre
    • Dose coordination was so poor that patient is likely to have received no dose or only received minimal dose
    Breezhaler Handihaler Turbohaler
    • Failed to remove capsule
    • Failed to insert capsule into the chamber
    • Did not completely close device capsule chamber
    • Did not pierce the capsule and failed to release piercing buttons fully before inhalation
    • Exhaled directly into mouthpiece
    • No seal by the lips round the mouthpiece during the inhalation
    • Capsule did not rattle
    • Failed to remove capsule
    • Failed to insert capsule into the chamber
    • Did not completely close device capsule chamber (heard click when satisfactory)
    • Did not pierce the capsule
    • Exhaled directly into mouthpiece
    • No seal by the lips round the mouthpiece during the inhalation
    • Capsule did not rattle
       
       
    • Failed to remove cap
    • Did not hold device upright (±45⁰) during dose preparation
    • Base not twisted fully backwards and forwards, no click heard
    • Shook the device after dose preparation
    • Exhaled directly into mouthpiece
    • No seal by the lips round the mouthpiece during the inhalation



       
       

The Ellipta Critical Errors data has been published in the NPJ – PCRM (Nature Partners Journal – Primary Care Respiratory Medicine).

Visit our COPD page to learn more about our medicines which are part of the Ellipta portfolio.

References

  1. Van der Palen, J., et al., NPJ Primary Care Respiratory Medicine, 2016. 26: p. 16079.
  2. Incruse SPC.
  3. Anoro SPC.
  4. Relvar SPC.
  5. Riley, J.H., et al., International Journal of Chronic Obstructive Pulmonary Disease, 2016. 11: p. 1873-1880.

Relvar and Ellipta are registered trademarks of the GlaxoSmithKline group of companies