Endotoxin Challenge Study For Healthy Men and Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515268
Recruitment Status : Completed
First Posted : August 13, 2007
Last Update Posted : August 7, 2017
Information provided by (Responsible Party):

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 Type : Interventional  (Clinical Trial)
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 : September 27, 2007
Actual Primary Completion Date : April 23, 2008
Actual Study Completion Date : April 23, 2008

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.

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 [ Time Frame: 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 [ Time Frame: Day 1,Day 7&DAY 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00515268

GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline Identifier: NCT00515268     History of Changes
Other Study ID Numbers: IPC103711
First Posted: August 13, 2007    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
LPS challenge,
Healthy volunteers

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action