October 24, 2006 |
October 15, 2008 |
August 2006 |
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 ] |
- 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.
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Complete list of historical versions of study NCT00392587 on ClinicalTrials.gov Archive Site |
- 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 ]
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- 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.
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A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease) |
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 |
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. |
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Phase II |
Interventional |
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: GW856553 |
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Completed |
30 |
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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
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Both |
40 Years to 75 Years |
No |
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Germany |
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NCT00392587 |
Study Director, GSK |
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GlaxoSmithKline |
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Study Director: |
GSK Clinical Trials, MD MSc FPPM |
GlaxoSmithKline |
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GlaxoSmithKline |
October 2008 |