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

Last updated: May 31, 2012
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

2

Condition

Emphysema

Chronic Obstructive Pulmonary Disease (Copd)

Bronchiectasis

Treatment

N/A

Clinical Study ID

NCT00144859
MKC101614
  • Ages 40-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion criteria:

  • Current diagnosis of asthma.

  • Active tuberculosis, sarcoidosis or bronchiectasis.

  • History of any type of malignancy, rheumatoid arthritis or other conditions associatedwith chronic inflammation.

  • Clinically significant renal or hepatic disease.

  • History of increased liver function tests, or patients receiving hormone replacementtherapy, statins or systemic or topical corticosteroids.

Study Design

Total Participants: 82
Study Start date:
July 01, 2005
Estimated Completion Date:

Connect with a study center

  • GSK Investigational Site

    Aalborg, DK-9100
    Denmark

    Site Not Available

  • GSK Investigational Site

    Kobenhavn NV, 2400
    Denmark

    Site Not Available

  • GSK Investigational Site

    Helsinki, 00029
    Finland

    Site Not Available

  • GSK Investigational Site

    Gauting, Bayern 82131
    Germany

    Site Not Available

  • GSK Investigational Site

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • GSK Investigational Site

    Grosshansdorf, Schleswig-Holstein 22927
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 20535
    Germany

    Site Not Available

  • GSK Investigational Site

    Dordrecht, 3317 NM
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Eindhoven, 5623 EJ
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Rotterdam, 3000 DR
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Liverpool, Lancashire L9 7AL
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Leicester, Leicestershire LE3 9QP
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Newcastle Upon Tyne, Northumberland NE7 7DN
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Belfast, BT9 6AB
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Hull, HU16 5JQ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, E2 9JX
    United Kingdom

    Site Not Available

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