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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144859
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Chronic Obstructive Pulmonary Disease (COPD) Drug: SB681323 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Primary Outcome Measures :
  1. Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)

Secondary Outcome Measures :
  1. Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144859

GSK Investigational Site
Aalborg, Denmark, DK-9100
GSK Investigational Site
Kobenhavn NV, Denmark, 2400
GSK Investigational Site
Helsinki, Finland, 00029
GSK Investigational Site
Gauting, Bayern, Germany, 82131
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
GSK Investigational Site
Hamburg, Germany, 20535
GSK Investigational Site
Dordrecht, Netherlands, 3317 NM
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
GSK Investigational Site
Rotterdam, Netherlands, 3000 DR
United Kingdom
GSK Investigational Site
Liverpool, Lancashire, United Kingdom, L9 7AL
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE3 9QP
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE7 7DN
GSK Investigational Site
Belfast, United Kingdom, BT9 6AB
GSK Investigational Site
Hull, United Kingdom, HU16 5JQ
GSK Investigational Site
London, United Kingdom, E2 9JX
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00144859     History of Changes
Other Study ID Numbers: MKC101614
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: March 2011

Keywords provided by GlaxoSmithKline:
P38 map kinase

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Anti-Inflammatory Agents