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A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01372410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2017-11-08

Study results available
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Summary

The purpose of this study is to further characterize the dose response of GSK573719 at doses of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the Handihaler will be included as an active control. A placebo treatment will be included in order to evaluate absolute treatment effect of the different doses of GSK573719.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

GSK573719

125 mcg once daily

DRUG

GSK573719

62.5 mcg once daily

DRUG

GSK573719

31.25 mcg once daily

DRUG

GSK573719

15.6 mcg once daily

DRUG

GSK573719

31.25 mcg twice daily

DRUG

GSK573719

15.6 mcg twice daily

DRUG

Tiotropium

18 mcg once daily

DRUG

Placebo

once or twice daily

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-01
Primary Completion
2011-10-01
Completion
2011-10-27

Countries

  • United States

Study Locations

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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 NCT01372410 on ClinicalTrials.gov