Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.

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).

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.