Patient perception of Breezhaler^® and Ellipta^® device feedback mechanisms in COPD: The ADVANTAGE Study

Abstract

Objectives: The primary objective of the ADVANTAGE study was to compare device-naïve chronic obstructive pulmonary disease (COPD) patients’ perception of the Breezhaler^® and Ellipta^® devices’ feedback mechanisms of dose delivery confirmation. The secondary objective was to assess comfort with the inhalers’ mouthpiece in terms of ease to form a tight seal around the mouthpiece. These objectives were achieved by using a novel, patient perception of inhaler questionnaire developed and tested during cognitive interviews of patients by Evidera, London, United Kingdom.

Methods: Ten COPD patients were interviewed to collect feedback on the interpretation, relevance and language of the questionnaire. This questionnaire was then used in ADVANTAGE to compare patients’ perception (n = 100) of both devices. Patients completed the questionnaire after a single inhalation of placebo through each inhaler.

Results: Using the final questionnaire, patients reported being more confident of the feedback mechanism of Breezhaler than that of the Ellipta device (mean score 4.3 versus 3.6 respectively, estimated difference [95% CI]: 0.75 [0.51, 0.99], p < .0001). Patients also reported better comfort (ease to form a tight seal with the lips) with the Breezhaler mouthpiece than the Ellipta mouthpiece (mean score 4.3 versus 3.9 respectively, estimated difference [95% CI]: 0.41 [0.21, 0.61], p < .0001). There were no safety concerns associated with either device.

Conclusion: COPD patients showed greater preference for the Breezhaler over the Ellipta inhaler for confidence of dose delivery and comfort of the mouthpiece.

Trial registration: ClinicalTrials.gov identifier: NCT02551224.

Keywords:

• Breezehaler
• COPD
• device
• dry powder inhaler
• feedback mechanism

Transparency

Declaration of funding

This study was sponsored by < grant sponsor > Novartis</grant sponsor > Pharma AG, Basel, Switzerland.

Author contributions: All authors contributed toward the data analysis, the drafting and revising of the paper and agree to be accountable for all aspects of this work.

Declaration of financial/other relationships

P.A. has disclosed that he is an employee of Novartis Pharmaceuticals Corporation, USA. M.A.B. has disclosed that he has received grants from Novartis during the conduct of the study; and personal fees from GSK, Astra Zeneca, Boehringer Ingelheim, Sanofi, Novartis, outside the submitted work. G.R.G. has disclosed that he has no significant relationships with or financial interests in any commercial companies related to this study or article. T.G. has disclosed that he is an employee of Novartis Product Lifecycle Services, Ireland. A.V.P. has disclosed that she is an employee of Novartis Argentina. J.L.W. has disclosed that he was an employee of Novartis Product Lifecycle Services, Ireland at the time of preparation of this manuscript.

A CMRO peer reviewer on this manuscript discloses involvement with clinical trials and consultation for Novartis Pharma AG, Basel, Switzerland. In the past 3 years, this reviewer has received compensation for consulting with AstraZeneca, Boehringer-Ingelheim, CSL Behring, Genentech, GlaxoSmithKline, Grifols, Kamada, Merck Frosst, Novartis, Roche and Sanofi; has undertaken research funded by Amgen, AstraZeneca, Baxter, Boehringer-Ingelheim, CSL Behring, GlaxoSmithKline, Grifols, Kamada, Novartis, Regeneron, Roche and Sanofi; and has participated in continuing medical education activities sponsored in whole or in part by AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Grifols, Merck Frosst and Novartis. Other CMRO peer reviewers on this manuscript have no financial or other relationships to disclose.

Acknowledgements

The authors are grateful to Savita Bakhshi Anand, Evan Davies and Margaret Vernon of Evidera (London, UK) for support in the cognitive interview process. The authors also thank Gillian Lavelle PhD (Novartis Product Lifecycle Services, Dublin, Ireland) and Praveen Kaul PhD (Novartis Healthcare Pvt. Ltd., India) for providing medical writing support, and to Claire Twomey PhD (Novartis Product Lifecycle Services, Dublin, Ireland) for providing editorial support, which was funded by Novartis Pharma AG, Basel, Switzerland in accordance with Good Publication Practice (GPP3) guidelines.