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A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00392587
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: GW856553
 Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

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 ]

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 ]

Enrollment: 30
Study Start Date: August 2006
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392587

Locations
Germany
GSK Investigational Site
Berlin, Germany, D-14050
Germany, Niedersachsen
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Germany, Schleswig-Holstein
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD MSc FPPM GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: MKI106209
Study First Received: October 24, 2006
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00392587  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
COPD

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 14, 2009



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