Endotoxin Challenge Study For Healthy Men and Women

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: GSK256066; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00515268

IPC103711

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 design

37 participants in 2 patient groups, including a placebo group

Subjects receiving GSK256066

Experimental group

Description:

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.

Treatment:

Drug: GSK256066

Subjects receiving placebo

Placebo Comparator group

Description:

Eligible subjects will be randomized to receive placebo for 7 days, administered via an ACCUHALER.

Treatment:

Drug: Placebo