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Corticosteroid

Cohort 4: Participants receiving FF/UMEC/VI at Dose level 4 via ELLIPTA inhaler for Asthma

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

Summary

The study aims to evaluate the efficacy, safety and tolerability of FF/UMEC/VI compared with FF/VI via ELLIPTA® inhaler in Chinese participants with inadequately controlled asthma. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cohorts 1 and 2: Change from Baseline in trough Forced expiratory volume in 1 second (FEV1) (Liters)
Secondary study objectives
Cohort 3 and 4: Change from Baseline in trough FEV1 (Liters)
Cohorts 1, 2 , 3 and 4: Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: Participants receiving FF/UMEC/VI at Dose level 4 via ELLIPTA inhalerExperimental Treatment2 Interventions
Group II: Cohort 3: Participants receiving FF/ VI at Dose level 3 via ELLIPTA inhalerExperimental Treatment2 Interventions
Group III: Cohort 2: Participants receiving FF/UMEC/VI at Dose level 2 via ELLIPTA inhalerExperimental Treatment2 Interventions
Group IV: Cohort 1: Participants receiving FF/VI at Dose level 1 via ELLIPTA inhalerExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FF/VI
2012
Completed Phase 3
~4280
FF/UMEC/VI
2022
Completed Phase 4
~7120
ELLIPTA
2018
Completed Phase 4
~2870

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,176,451 Total Patients Enrolled
300 Trials studying Asthma
500,176 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,601 Previous Clinical Trials
6,144,658 Total Patients Enrolled
229 Trials studying Asthma
401,894 Patients Enrolled for Asthma
~0 spots leftby Sep 2024
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