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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144859
• Other study ID #: MKC101614
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: May 31, 2012
• Start date: July 2005

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• SB681323

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Kobenhavn NV
Finland	GSK Investigational Site	Helsinki
Germany	GSK Investigational Site	Gauting	Bayern
Germany	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Netherlands	GSK Investigational Site	Dordrecht
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Maastricht
Netherlands	GSK Investigational Site	Rotterdam
United Kingdom	GSK Investigational Site	Belfast
United Kingdom	GSK Investigational Site	Hull
United Kingdom	GSK Investigational Site	Leicester	Leicestershire
United Kingdom	GSK Investigational Site	Liverpool	Lancashire
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Newcastle Upon Tyne	Northumberland

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Finland,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
Secondary	Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics