Endotoxin Challenge Study For Healthy Men and Women

NCT ID: NCT00515268

Last Updated: 2017-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-27

Study Completion Date

2008-04-23

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Study Groups

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Subjects receiving GSK256066

Eligible subjects will be randomized to receive GSK256066 with inhaled doses of 25 micrograms or 87.5 micrograms once daily for 7 days, administered via an ACCUHALER.

Group Type EXPERIMENTAL

GSK256066

Intervention Type DRUG

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

Subjects receiving placebo

Eligible subjects will be randomized to receive placebo for 7 days, administered via an ACCUHALER.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive placebo inhaler.

Interventions

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GSK256066

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

Intervention Type DRUG

Placebo

Subjects will receive placebo inhaler.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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IPC103711

Identifier Type: -

Identifier Source: org_study_id

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