Status:
COMPLETED
Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
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 Di...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00144859
Start Date
July 1 2005
Last Update
June 4 2012
Active Locations (17)
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1
GSK Investigational Site
Aalborg, Denmark, DK-9100
2
GSK Investigational Site
København NV, Denmark, 2400
3
GSK Investigational Site
Helsinki, Finland, 00029
4
GSK Investigational Site
Gauting, Bavaria, Germany, 82131