NCT00869596

Study of Biomarkers of Airway Inflammation (0000-128)

A Randomized Clinical Trial to Assess the Effects of Inhaled Fluticasone on Sputum Neutrophils After Low-dose Inhaled Endotoxin Challenge in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide.

Conditions

• Airway Inflammation

Interventions

Type	Name	Description
DRUG	fluticasone propionate	Single dose of fluticasone 440 mcg (2 x 220 mcg) or 1980 mcg (9 x 220 mcg) by metered dose inhaler in two of three treatment periods
DRUG	Comparator: Placebo to fluticasone	Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
DRUG	Comparator: Lipopolysaccharide (LPS)	20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
DRUG	Comparator: albuterol	Albuterol two 100 mcg inhalations by metered dose inhaler prior to sputum induction at screening, twice during each of the three treatment periods, and at the post-study follow up visit.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-03-26
• Last updated: 2015-07-23