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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

NCT01772134 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2018-01-29

Study results available
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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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Umeclidinium bromide 62.5mcg

Inhalation Powder, LAMA 62.5mcg

DRUG

Umeclidinium bromide 125mcg

Inhalation Powder, LAMA 125mcg

DRUG

Fluticasone propionate 250mcg/Salmeterol 50mcg

Inhalation Powder, ICS/LABA

DRUG

Placebo

Inhalation Powder, Placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2013-07-01
Completion
2013-07-22

Countries

  • United States
  • Canada
  • Germany
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01772134 on ClinicalTrials.gov