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Corticosteroid/Beta2-agonist Combination

Umeclidinium bromide 62.5 + Fluticasone propionate/Salmeterol 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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 1-12
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Eligible Conditions
  • Asthma
  • Chronic Obstructive Pulmonary Disease

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85
Secondary study objectives
Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84
Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12
Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Umeclidinium bromide 62.5 + Fluticasone propionate/SalmeterolExperimental Treatment2 Interventions
Long-acting muscarinic antagonist (LAMA), 62.5mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg
Group II: Umeclidinium bromide 125 + Fluticasone propionate/SalmeterolActive Control2 Interventions
Long-acting muscarinic antagonist (LAMA), 125mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg
Group III: Placebo + Fluticasone propionate/SalmeterolPlacebo Group2 Interventions
Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluticasone propionate
FDA approved
Umeclidinium
FDA approved

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,805 Previous Clinical Trials
8,378,885 Total Patients Enrolled
302 Trials studying Asthma
500,622 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,253 Total Patients Enrolled
231 Trials studying Asthma
402,351 Patients Enrolled for Asthma
~48 spots leftby Nov 2025
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