Back to results

Endotoxin Challenge Study For Healthy Men and Women

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

GSK256066

Placebo

About this trial

This is an interventional diagnostic trial for Pulmonary Disease, Chronic Obstructive focused on measuring LPS challenge,, Healthy volunteers

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Subjects receiving GSK256066

Subjects receiving placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00515268

First Posted

August 9, 2007

Last Updated

August 4, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00515268

Brief Title

Endotoxin Challenge Study For Healthy Men and Women

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

September 27, 2007 (Actual)

Primary Completion Date

April 23, 2008 (Actual)

Study Completion Date

April 23, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

LPS challenge,, Healthy volunteers

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects receiving GSK256066

Arm Type

Experimental

Arm Description

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.

Arm Title

Subjects receiving placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GSK256066

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects will receive placebo inhaler.

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Endotoxin Challenge Study For Healthy Men and Women

We'll reach out to this number within 24 hrs