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

May 31, 2012 updated by: GlaxoSmithKline

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9100
        • GSK Investigational Site
      • Kobenhavn NV, Denmark, 2400
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
  • Germany
      • Hamburg, Germany, 20535
        • GSK Investigational Site
    • Bayern
      • Gauting, Bayern, Germany, 82131
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
    • Schleswig-Holstein
      • Grosshansdorf, Schleswig-Holstein, Germany, 22927
        • GSK Investigational Site
  • Netherlands
      • 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
        • GSK Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT9 6AB
        • GSK Investigational Site
      • Hull, United Kingdom, HU16 5JQ
        • GSK Investigational Site
      • London, United Kingdom, E2 9JX
        • GSK Investigational Site
    • Lancashire
      • Liverpool, Lancashire, United Kingdom, L9 7AL
        • GSK Investigational Site
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE3 9QP
        • GSK Investigational Site
    • Northumberland
      • Newcastle Upon Tyne, Northumberland, United Kingdom, NE7 7DN
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (ESTIMATE)

September 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC101614

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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