Back to resultsA Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
GW856553
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pharmacodynamics, Pharmacokinetics, Tolerability, COPD, Safety
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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00392587
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Pharmacodynamics, Pharmacokinetics, Tolerability, COPD, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW856553
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.
Time Frame
after 7 and 14 days of dosing
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
GSK Investigational Site
City
Grosshansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23254770
Citation
Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.
Results Reference
derived
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A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)
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