Endotoxin Challenge Study For Healthy Men and Women
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|ClinicalTrials.gov Identifier: NCT00515268|
Recruitment Status : Completed
First Posted : August 13, 2007
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: GSK256066 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||September 27, 2007|
|Actual Primary Completion Date :||April 23, 2008|
|Actual Study Completion Date :||April 23, 2008|
Experimental: 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.
GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.
Placebo Comparator: Subjects receiving placebo
Eligible subjects will be randomized to receive placebo for 7 days, administered via an ACCUHALER.
Subjects will receive placebo inhaler.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515268
|GSK Investigational Site|
|Hannover, Niedersachsen, Germany, 30625|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|