Pulmonary Disease, Chronic Obstructive Clinical Trial
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
| NCT number | NCT00392587 |
| Other study ID # | MKI106209 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | October 24, 2006 |
| Last updated | May 31, 2012 |
| Start date | August 2006 |
| Verified date | March 2011 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Grosshansdorf | Schleswig-Holstein |
| Germany | GSK Investigational Site | Hannover | Niedersachsen |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 14 days | ||
| Secondary | Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing. | after 7 and 14 days of dosing | ||
| Secondary | 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 |
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