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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Anti-Inflammatory Agents

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.