Endotoxin Challenge Study For Healthy Men and Women
|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|
|Primary Completion Date :||April 23, 2008|
|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 ]
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|