Last updated: 11/04/2018 08:24:53

Endotoxin Challenge Study For Healthy Men and Women

GSK study ID
IPC103711
See study documents
Clinicaltrials.gov ID
NCT00515268
EudraCT ID
2007-001935-75
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

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

Timeframe: 24 hours

Secondary outcomes:

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

Timeframe: Day 1,Day 7&DAY 8

Interventions:
Drug: GSK256066
Drug: Placebo
Enrollment:
37
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
GSK256066
Collaborators
Not applicable
Study date(s)
September 2007 to April 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • Healthy males and females (contraception restrictions),
  • 18-50yrs,
  • Abnormal troponin and/or CK MB,
  • Participated in any GSK study involving the administration of COA for >/= 21 days.
Inclusion and exclusion criteria
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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Will Be Recruiting
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-23-04

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study IPC103711 can be found on the GSK Clinical Study Register.
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