An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA DPI in Pediatric Subjects With Asthma
Status:
Completed
Trial end date:
2018-12-07
Target enrollment:
Participant gender:
Summary
Asthma is a chronic inflammatory disease of airways and lungs that results in
hyper-reactivity and clinically relevant episodes of wheezing. This study has been designed
to assess the correct use and ease of use of the ELLIPTA® DPI in pediatric subjects with
asthma. ELLIPTA DPI is easy to use, requires few steps, is consistent in dosing and
eliminates the hand-breath co-ordination required for metered dose inhalers (MDIs). Subjects
will be stratified by age into two strata: Stratum 1: subjects in the age group of 5 to 7
years and Stratum 2: Subjects in the age group of 8 to 11 years. All subjects will be trained
by Health care professionals (HCP) for the correct use of ELLIPTA DPI. Subjects will be given
three chances to attempt correct use of ELLIPTA DPI; subsequently, if the subject is not
successful, the parent/guardian will be able to help instruct the subject on the correct use
of the ELLIPTA DPI, for two more attempts. The subjects who will be enrolled in the study
will take placebo ELLIPTA DPI once daily. After 28 days subjects will be randomized in 1:1 to
receive a questionnaire (Version A and B). After completion of the questionnaire on ELLIPTA
DPI ease of use, subject's ability to use ELLIPTA DPI correctly will be re-assessed.
Approximately 219 subjects will be screened to participate in the study. The study will be
conducted for 28 days. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of
companies.