A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT01009463 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1626

Last updated 2017-11-09

Study results available
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Summary

The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

FF/GW642444 Inhalation Powder

Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) delivered within one dry powder inhaler (DPI) device for COPD

DRUG

GW642444 Inhalation Powder

Long Acting Beta Agonist(LABA) Inhalation Powder via DPI

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
2009-09-25
Primary Completion
2011-10-01
Completion
2011-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Chile
  • Estonia
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • Peru
  • Philippines
  • South Africa
  • Sweden
  • United Kingdom

Study Locations

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Entities

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 NCT01009463 on ClinicalTrials.gov