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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144859

Enrollment

Registered

2005-09-05

Start date

2005-07-31

Completion date

Unknown

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease, Chronic Obstructive

Keywords

P38 map kinase, CRP, COPD, safety

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).

Interventions

DRUGSB681323

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)	—

Secondary

Measure	Time frame
Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics	—

Countries

Denmark, Finland, Germany, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026