Clinical trial NCT00144859: Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: P38 map kinase
CRP
COPD
safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
Secondary outcomes:
measure: Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: GSK Investigational Site
city: Kobenhavn NV
country: Denmark
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Gauting
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Grosshansdorf
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Dordrecht
country: Netherlands
facility: GSK Investigational Site
city: Eindhoven
country: Netherlands
facility: GSK Investigational Site
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Leicester
country: United Kingdom
facility: GSK Investigational Site
state: Leicestershire
city: Newcastle Upon Tyne
country: United Kingdom
facility: GSK Investigational Site
state: Northumberland
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: