Endotoxin Challenge Study For Healthy Men and Women
Phase 1
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Placebo
- Registration Number
- NCT00515268
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subjects receiving GSK256066 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. Subjects receiving placebo Placebo Eligible subjects will be randomized to receive placebo for 7 days, administered via an ACCUHALER.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Hannover, Niedersachsen, Germany