NCT00392587

Brief Summary

The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

3 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

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
Last Updated

June 4, 2012

Status Verified

March 1, 2011

First QC Date

October 24, 2006

Last Update Submit

May 31, 2012

Conditions

Pulmonary Disease, Chronic ObstructiveChronic Obstructive Pulmonary Disease (COPD)

Keywords

PharmacodynamicsPharmacokineticsTolerabilityCOPDSafety

Outcome Measures

Primary Outcomes (1)

  • Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.

    14 days

Secondary Outcomes (2)

  • Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.

    after 7 and 14 days of dosing

  • Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.

    after 1, 3, 7, 10 and 14 days of dosing

Interventions

GW856553DRUG

Eligibility Criteria

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

You may qualify if:

  • Women of childbearing potential
  • Established history of COPD
  • Cigarette smoking history greater than 10 pack years
  • FEV1 between 40 and 80% of predicted normal for height, age and sex.

You may not qualify if:

  • Morbidly obese patients (body mass index \>40)
  • Hospitalisation or treatment for worsening of COPD in past 6 weeks
  • History of increased liver function tests
  • hypersensitivity to salbutamol or ipratropium bromide
  • Blood pressure \> 155/95

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 14050, Germany

Location

Related Publications (1)

  • Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.

    PMID: 23254770DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

6-(5-((cyclopropylamino)carbonyl)-3-fluoro-2-methylphenyl)-N-(2,2-dimethylprpyl)-3-pyridinecarboxamide

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

October 24, 2006

First Posted

October 26, 2006

Study Start

August 1, 2006

Last Updated

June 4, 2012

Record last verified: 2011-03

Locations

DE(3)