MedTrace Logo

An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B

NCT01323660 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2018-02-15

Study results available
· View outcomes & findings →

Summary

This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI).

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

GSK573719/GW642444 125/25

125mcg/ 25mcg QID (Once daily , inhaled)

DRUG

GSK573719/GW642444 62.5/25

62.5mcg/25mcg QID

DRUG

GSK573719 125

125mcg QID

DRUG

GSK573719 62.5

62.5mcg QID

DRUG

GW642444 25

25mcg QID

DEVICE

placebo

Comparator QID

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-16
Primary Completion
2012-07-01
Completion
2012-07-16

Countries

  • United States
  • Canada
  • Czechia
  • Denmark
  • South Africa
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01323660 on ClinicalTrials.gov