NCT03478657

An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA DPI in Pediatric Subjects With Asthma

An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA Dry Powder Inhaler (DPI) in Pediatric Patients Currently Receiving Inhaled Therapy for Treatment of Their Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Placebo DPI	Subjects will receive placebo via oral inhalation route using ELLIPTA once daily. Placebo DPI will be available in two strips of 30 blisters per strip. First strip will contain lactose monohydrate and second strip will have lactose monohydrate blended with magnesium stearate.
DEVICE	ELLIPTA DPI	Subjects will receive placebo DPI via ELLIPTA. ELLIPTA is trademark of GSK
OTHER	Ease of use questionnaires	Subjects from both stratum after use of ELLIPTA DPI will be randomized to receive either version A or B of the questionnaires. Subjects will be asked questions on ease of use of ELLIPTA. Parent/guardian will also complete a questionnaire about the ELLIPTA DPI.

Timeline

• Start date: 2018-06-18
• Primary completion: 2018-12-07
• Completion: 2018-12-07
• First posted: 2018-03-27
• Last updated: 2021-03-26
• Results posted: 2019-12-09

Locations

19 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study