Back to resultsSafety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SB681323
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring P38 map kinase, CRP, COPD, safety
Eligibility Criteria
Inclusion criteria: Non-childbearing potential. Clinical diagnosis of COPD. Cigarette smoking history of greater than or equal to 10 pack years. Post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) < 0.7 Post-bronchodilator FEV1 50% - 80% of predicted normal. Receiving inhaled corticosteroids for a minimum of 6 weeks prior to Screening. Serum CRP concentration greater than 3mg/L. Exclusion criteria: Current diagnosis of asthma. Active tuberculosis, sarcoidosis or bronchiectasis. History of any type of malignancy, rheumatoid arthritis or other conditions associated with chronic inflammation. Clinically significant renal or hepatic disease. History of increased liver function tests, or patients receiving hormone replacement therapy, statins or systemic or topical corticosteroids.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
Secondary Outcome Measures
Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00144859
Brief Title
Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A 28-day, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 7.5 mg Per Day in Patients With Chronic Obstructive Pulmonary Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (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
5. Study Description
Brief Summary
This is a 28-day, placebo controlled clinical study assessing the safety, tolerability anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic Obstructive Pulmonary Disease).
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
P38 map kinase, CRP, COPD, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
82 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SB681323
Primary Outcome Measure Information:
Title
Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
Secondary Outcome Measure Information:
Title
Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics
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:
Non-childbearing potential.
Clinical diagnosis of COPD.
Cigarette smoking history of greater than or equal to 10 pack years.
Post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) < 0.7
Post-bronchodilator FEV1 50% - 80% of predicted normal.
Receiving inhaled corticosteroids for a minimum of 6 weeks prior to Screening.
Serum CRP concentration greater than 3mg/L.
Exclusion criteria:
Current diagnosis of asthma.
Active tuberculosis, sarcoidosis or bronchiectasis.
History of any type of malignancy, rheumatoid arthritis or other conditions associated with chronic inflammation.
Clinically significant renal or hepatic disease.
History of increased liver function tests, or patients receiving hormone replacement therapy, statins or systemic or topical corticosteroids.
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
Aalborg
ZIP/Postal Code
DK-9100
Country
Denmark
Facility Name
GSK Investigational Site
City
Kobenhavn NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
GSK Investigational Site
City
Gauting
State/Province
Bayern
ZIP/Postal Code
82131
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
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
Hamburg
ZIP/Postal Code
20535
Country
Germany
Facility Name
GSK Investigational Site
City
Dordrecht
ZIP/Postal Code
3317 NM
Country
Netherlands
Facility Name
GSK Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3000 DR
Country
Netherlands
Facility Name
GSK Investigational Site
City
Liverpool
State/Province
Lancashire
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Newcastle Upon Tyne
State/Province
Northumberland
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Belfast
ZIP/Postal Code
BT9 6AB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
E2 9JX
Country
United Kingdom
12. IPD Sharing Statement
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Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
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