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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00144859
First received: September 1, 2005
Last updated: May 31, 2012
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: SB681323
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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

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

Estimated Enrollment: 82
Study Start Date: July 2005
Intervention Details:
    Drug: SB681323
    Other Name: SB681323
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144859

Locations
Denmark
GSK Investigational Site
Aalborg, Denmark, DK-9100
GSK Investigational Site
Kobenhavn NV, Denmark, 2400
Finland
GSK Investigational Site
Helsinki, Finland, 00029
Germany
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
Netherlands
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00144859     History of Changes
Other Study ID Numbers: MKC101614
Study First Received: September 1, 2005
Last Updated: May 31, 2012
Health Authority: Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency

Keywords provided by GlaxoSmithKline:
P38 map kinase
CRP
COPD
safety

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
 Pathologic Processes
Respiratory Tract Diseases
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013