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Corticosteroid

FF/VI via ELLIPTA DPI for Asthma

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 1-12
Awards & highlights

Summary

This trial is designed to compare the efficacy and safety of an asthma medication combination of an inhaled corticosteroid and long-acting beta agonist versus an inhaled corticosteroid alone in children and adolescents aged 5-17 years old with uncontrolled asthma. A total of 870 subjects will be randomized in the study, 652 of which will be aged 5-11 years and 218 of which will be aged 12-17 years. The study will last for a total of 29 weeks and subjects will use a rescue medication of short acting beta 2 agonist as needed throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 1-12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 1-12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Weighted Mean of Forced Expiratory Volume in 1 Second (FEV1) (0-4 Hours) at Week 12 in 5-17 Year Old Population
Change From Baseline in Mean Pre-dose Morning Peak Expiratory Flow (AM PEF) in 5-11 Year Old Population
Secondary outcome measures
Absolute Weighted Mean of FEV1 (0-4 Hours) at Week 12 in 5-11 Year Old Population
Change From Baseline ACQ-5 Score at Week 24 in 5-11 Year Old Population
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24 in 5-17 Year Old Population
+15 more

Side effects data

From 2022 Phase 3 trial • 906 Patients • NCT03248128
8%
Nasopharyngitis
6%
Upper respiratory tract infection
2%
Headache
1%
Rhinitis
1%
Rhinitis allergic
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Participants Who Received FF
Participants Who Received FF/ VI FDC

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Subjects receiving FF/VI in cohort BExperimental Treatment1 Intervention
Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 100/25 mcg administered once daily in the morning via ELLIPTA DPI.
Group II: Subjects receiving FF/VI in cohort AExperimental Treatment1 Intervention
Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 50/25 mcg administered once daily in the morning via ELLIPTA DPI.
Group III: Subjects receiving FF in cohort AActive Control1 Intervention
Subjects will be randomized in 1:1 ratio to receive FF with a dose of 50 mcg administered once daily in the morning via ELLIPTA DPI.
Group IV: Subjects receiving FF in cohort BActive Control1 Intervention
Subjects will be randomized in 1:1 ratio to receive FF with a dose of 100 mcg administered once daily in the morning via ELLIPTA DPI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FF/VI via ELLIPTA DPI
2017
Completed Phase 3
~910

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,175,901 Total Patients Enrolled
300 Trials studying Asthma
499,626 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,601 Previous Clinical Trials
6,144,108 Total Patients Enrolled
229 Trials studying Asthma
401,344 Patients Enrolled for Asthma
~116 spots leftby Sep 2025
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