NCT03478657 - An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA DPI in Pediatric Subjects With Asthma | Biotech Hunter

Enrollment

222

Participants

Timeline

Start Date

June 18, 2018

Primary Completion Date

December 7, 2018

Study Completion Date

December 7, 2018

Conditions

Asthma

Interventions

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.

Trial Locations (19)

28801

GSK Investigational Site, Asheville

29485

GSK Investigational Site, Summerville

33173

GSK Investigational Site, Miami

33180

GSK Investigational Site, Aventura

33324

GSK Investigational Site, Plantation

42301

GSK Investigational Site, Owensboro

55402

GSK Investigational Site, Minneapolis

55441

GSK Investigational Site, Plymouth

65203

GSK Investigational Site, Columbia

65401

GSK Investigational Site, Rolla

72205

GSK Investigational Site, Little Rock

76712

GSK Investigational Site, Waco

92648

GSK Investigational Site, Huntington Beach

94558

GSK Investigational Site, Napa

78759-8950

GSK Investigational Site, Austin

L6T 0G1

GSK Investigational Site, Brampton

L7N 3V2

GSK Investigational Site, Burlington

N6A 1V2

GSK Investigational Site, London

N8X 2G1

GSK Investigational Site, Windsor