NCT00144859

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
5 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

June 4, 2012

Status Verified

March 1, 2011

First QC Date

September 1, 2005

Last Update Submit

May 31, 2012

Conditions

Pulmonary Disease, Chronic ObstructiveChronic Obstructive Pulmonary Disease (COPD)

Keywords

P38 map kinaseCRPCOPDsafety

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

SB681323DRUG

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

GSK Investigational Site

Aalborg, DK-9100, Denmark

Location

GSK Investigational Site

København NV, 2400, Denmark

Location

GSK Investigational Site

Helsinki, 00029, Finland

Location

GSK Investigational Site

Gauting, Bavaria, 82131, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 20535, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Dordrecht, 3317 NM, Netherlands

Location

GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

Location

GSK Investigational Site

Maastricht, 6229 HX, Netherlands

Location

GSK Investigational Site

Rotterdam, 3000 DR, Netherlands

Location

GSK Investigational Site

Liverpool, Lancashire, L9 7AL, United Kingdom

Location

GSK Investigational Site

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

GSK Investigational Site

Newcastle upon Tyne, Northumberland, NE7 7DN, United Kingdom

Location

GSK Investigational Site

Belfast, BT9 6AB, United Kingdom

Location

GSK Investigational Site

Hull, HU16 5JQ, United Kingdom

Location

GSK Investigational Site

London, E2 9JX, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

dilmapimod

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

July 1, 2005

Last Updated

June 4, 2012

Record last verified: 2011-03

Locations

GB(6)NL(4)DE(4)DK(2)FI(1)