Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
LPS challenge,, Healthy volunteers
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.
Interventions
DRUGGSK256066
GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.
DRUGPlacebo
Subjects will receive placebo inhaler.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed