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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: SB681323

Study type

Interventional

Funder types

Industry

Identifiers

NCT00144859

MKC101614

Details and patient eligibility

About

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).

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.