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Corticosteroid/Beta2-agonist Combination

Efficacy and Safety of the Addition of Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide (62.5 or 125mcg) Once-daily Over 12 Weeks

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
  • 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
4,815 Previous Clinical Trials
8,383,573 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,609 Previous Clinical Trials
6,144,942 Total Patients Enrolled
~48 spots leftby Dec 2025
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