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NCT00515268 Clinical Trial

Endotoxin Challenge Study For Healthy Men and Women

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00515268
Other study ID # IPC103711
Secondary ID
Status Completed
Phase Phase 1
First received August 9, 2007
Last updated August 4, 2017
Start date September 27, 2007
Est. completion date April 23, 2008

Study information
Verified date August 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date April 23, 2008
Est. primary completion date April 23, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GSK256066
GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.
• Placebo
Subjects will receive placebo inhaler.

Locations
Country Name City State
Germany GSK Investigational Site Hannover Niedersachsen

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 24 hours
Secondary 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 Day 1,Day 7&DAY 8
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