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The evaluation of the correct use and ease‐of use of the ELLIPTA DPI in children with asthma
Author(s) -
Halverson Philip,
Liem Joel,
Heyes Logan,
Preece Andy,
Bareille Philippe,
Rees Jamie,
Jain Renu,
Stanford Richard H.,
Lenney Warren,
Collison Kathryn,
Sharma Raj
Publication year - 2021
Publication title -
pediatric pulmonology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.866
H-Index - 106
eISSN - 1099-0496
pISSN - 8755-6863
DOI - 10.1002/ppul.25149
Subject(s) - medicine , inhaler , asthma , dry powder inhaler , placebo , pediatrics , physical therapy , multicenter study , randomized controlled trial , alternative medicine , pathology
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.