Endotoxin Challenge Study For Healthy Men and Women

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00515268
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: GSK256066; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Primary Purpose: Diagnostic
• 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: Sep 27, 2007
• Actual Primary Completion Date: Apr 23, 2008
• Actual Study Completion Date: Apr 23, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: GSK256066; 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.	Drug: Placebo; Subjects will receive placebo inhaler.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00515268
• Other Study ID Numbers: IPC103711
• First Posted: Aug 13, 2007
• Last Update Posted: Aug 7, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by GlaxoSmithKline: LPS challenge,; Healthy volunteers
• Additional relevant MeSH terms: Pulmonary Disease, Chronic Obstructive; 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide

Study Results

No Results Posted as of Aug 7, 2017