The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma
Philip Halverson, Joel Liem, Logan Heyes, Andy Preece, Philippe Bareille, Jamie Rees, Renu Jain, Richard H Stanford, Warren Lenney, Kathryn Collison, Raj Sharma, Philip Halverson, Joel Liem, Logan Heyes, Andy Preece, Philippe Bareille, Jamie Rees, Renu Jain, Richard H Stanford, Warren Lenney, Kathryn Collison, Raj Sharma
Abstract
Rationale: Asthma studies show many children use inhalers incorrectly even after instruction. For two age groups of children with asthma, we determined the proportions who used the once-daily ELLIPTA dry-powder inhaler (DPI) correctly, and who found it easy to use.
Methods: This was a multicenter, single-arm, stratified, open-label, placebo study (NCT03478657). Children aged 5-7 and 8-11 years were trained in, and required to demonstrate, correct placebo ELLIPTA DPI use at their first clinic visit. The inhaler was used at home once daily for 28 ± 2 days. On returning to the clinic, children were randomized to an age-appropriate, ease-of-use questionnaire that had been developed and validated previously, and which rated the inhaler as "easy" or "hard" to use. Following questionnaire completion, children were then asked to demonstrate correct inhaler use. Correct use and ease-of use were assessed in each age group (co-primary endpoints) and overall (secondary endpoints).
Results: Of 222 enrolled children, 221 completed the study. Among children aged 5-7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared with 93% (n = 124/133) aged 8-11 years. Of these children, 98% (5-7 years: n = 79/81; 8-11 years: n = 121/124) rated the inhaler easy to use. Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use.
Conclusion: ELLIPTA DPI was used correctly and easily by most children on their first attempt without additional training.
Trial registration: ClinicalTrials.gov NCT03478657 NCT03315572.
Keywords: dry-powder inhaler; questionnaire; technique.
Conflict of interest statement
Philip Halverson and Joel Liem contributed to acquisition of data. Kathryn Collison, Logan Heyes, Renu Jain, Warren Lenney, Raj Sharma, Jamie Rees, Andy Preece, Philippe Bareille, and Richard Stanford contributed to study conception and/or design, and data analysis and/or interpretation. All authors contributed to writing and critically revising the manuscript for important intellectual content.
© 2020 The Authors. Pediatric Pulmonology Published by Wiley Periodicals LLC.
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Source: PubMed