A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo for Fluticasone Propionate; Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01364519

A9011082

Details and patient eligibility

About

Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment of inflammation will be via sputum induction.

Full description

Methodology Validation

Enrollment: 17 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• Normoresponsive airways - histamine PC20>16mg/mL
• Able to complete sputum induction successfully

Exclusion criteria

• Non (or ex) smokers
• No LPS challenge in previous 4 weeks

Trial design

17 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Fluticasone Propionate

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo for Fluticasone Propionate