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Completed

NCT Number: NCT00515268

Endotoxin Challenge Study For Healthy Men and Women

The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males and females (contraception restrictions),
  • 18-50yrs,
  • BMI 19-31kg/m2,
  • Non-smokers,
  • FEV1 >/= 80% predicted

Exclusion criteria

  • Abnormal troponin and/or CK MB,
  • Participated in any GSK study involving the administration of COA for >/= 21 days.

Treatment and study plan

GSK256066

Drug

GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.

Placebo

Drug

Subjects will receive placebo inhaler.

Primary outcomes

  1. Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure

    Time frame: 24 hours

Secondary outcomes

  1. Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8

    Time frame: Day 1,Day 7&DAY 8

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Double Blind, Placebo Controlled, Repeat Dose Study to Compare the Effectiveness of Two Doses of GSK256066 With Placebo in Reducing Lung Inflammation Following Segmental LPS Challenge in Healthy Volunteers

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2007
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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