A Randomised, Double-blind, Placebo-controlled Parallel Study to Assess the Safety, Tolerability,Pharmacodynamics and Steady State Pharmacokinetics of Repeated Doses of GW856553 in Patients With COPD

GlaxoSmithKline1 site in 1 country30 target enrollmentAugust 2006

ConditionsPulmonary Disease, Chronic Obstructive Chronic Obstructive Pulmonary Disease (COPD)

DrugsGW856553

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Enrollment: 30
Locations: 1
Primary Endpoint: Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.

Time Frame: 14 days

Secondary Outcomes

Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.(after 1, 3, 7, 10 and 14 days of dosing)
Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.(after 7 and 14 days of dosing)