Ease-of-use preference for the ELLIPTA^® dry powder inhaler over a commonly used single-dose capsule dry powder inhaler by inhalation device-naïve Japanese volunteers aged 40 years or older

Abstract

Background

In patients receiving inhaled medication, dissatisfaction with and difficulty in using the inhaler can affect treatment adherence. The incidence of handling errors is typically higher in the elderly than in younger people. The aim of the study was to assess inhaler preference for and handling errors with the ELLIPTA^® dry powder inhaler (DPI), (GSK), compared with the established BREEZHALER™, a single-dose capsule DPI (Novartis), in inhalation device-naïve Japanese volunteers aged ≥40 years.

Methods

In this open-label, nondrug interventional, crossover DPI preference study comparing the ELLIPTA DPI and BREEZHALER, 150 subjects were randomized to handle the ELLIPTA or BREEZHALER DPIs until the point of inhalation, without receiving verbal or demonstrative instruction (first attempt). Subjects then crossed over to the other inhaler. Preference was assessed using a self-completed questionnaire. Inhaler handling was assessed by a trained assessor using a checklist. Subjects did not inhale any medication in the study, so efficacy and safety were not measured.

Results

The ELLIPTA DPI was preferred to the BREEZHALER by 89% of subjects (odds ratio [OR] 70.14, 95% confidence interval [CI] 33.69–146.01; P-value not applicable for this inhaler) for ease of use, by 63% of subjects (OR 2.98, CI 1.87–4.77; P<0.0001) for ease of determining the number of doses remaining in the inhaler, by 91% for number of steps required, and by 93% for time needed for handling the inhaler. The BREEZHALER was preferred to the ELLIPTA DPI for comfort of the mouthpiece by 64% of subjects (OR 3.16, CI 1.97–5.06; P<0.0001). The incidence of handling errors (first attempt) was 11% with ELLIPTA and 68% with BREEZHALER; differences in incidence were generally similar when analyzed by age (< or ≥65 years) or sex.

Conclusion

These data, obtained in an inhalation device-naïve population, suggest that the ELLIPTA DPI is preferred to an established alternative based on its ease-of-use features and is associated with fewer handling errors.

Keywords:

• chronic obstructive pulmonary disease
• dry powder inhaler
• ELLIPTA^®
• BREEZHALER™

Supplementary materials

Figure S1 Subject preference for the ELLIPTA^® DPI versus the BREEZHALER™ DPI by age and sex. (A) <65 years, (B) ≥65 years of age, (C), male, and (D) female.

Abbreviations: CI, confidence interval; DPI, dry powder inhaler.

Table S1 Overall number of handling errors, in the second attempted use of the ELLIPTA^® DPI or BREEZHALER™, following nonverbal demonstrative instruction

Author contributions

YK, AK, and RS participated in the conception and design of the study, and in analysis and interpretation of the data. AA participated in the conception and design of the study, acquisition of data, and analysis and interpretation of the data. All authors revised the manuscript and read and approved the final version.

Disclosure

YK provided paid consultancy services to GSK for administration of this study and has received financial reimbursement from GSK for providing lecture services. AA, AK, and RS are employed by GSK, and RS also owns stocks in GSK. This study was funded by GSK (study number 200372). Editorial support in the form of development of the draft outline in consultation with the authors, development of the first draft of the manuscript in consultation with the authors, editorial suggestions to draft versions of this paper, assembling tables and figures, collating author comments, copyediting, fact checking, referencing, and graphic services were provided by David Cutler at Gardiner-Caldwell Communications (Macclesfield, UK) and was funded by GSK.