A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 24, 2006

Last Updated Date

October 15, 2008

Start Date ^†

August 2006

Current Primary Outcome Measures ^†

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 ]

Original Primary Outcome Measures ^†

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.

Change History

Complete list of historical versions of study NCT00392587 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing. [ Time Frame: after 7 and 14 days of dosing ]
Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing. [ Time Frame: after 1, 3, 7, 10 and 14 days of dosing ]

Original Secondary Outcome Measures ^†

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

Descriptive Information

Brief Title ^†

A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^†

Drug: GW856553

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion criteria:

Women of childbearing potential
Established history of COPD
Cigarette smoking history greater than 10 pack years
FEV1 between 40 and 80% of predicted normal for height, age and sex.

Exclusion criteria:

Morbidly obese patients (body mass index >40)
Hospitalisation or treatment for worsening of COPD in past 6 weeks
History of increased liver function tests
hypersensitivity to salbutamol or ipratropium bromide
Blood pressure > 155/95

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00392587

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD MSc FPPM

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.