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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
22
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
Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
Sputum percent neutrophils
Time frame: 6 hours following inhaled LPS challenge
Sputum absolute neutrophils (per mL)
Time frame: 6 hours following inhaled LPS challenge
Sputum levels of IL1beta and IL8
Time frame: 6 hours following inhaled LPS challenge
Sputum mRNA expression levels of CD14 and IL1beta
Time frame: 6 hours following inhaled LPS challenge
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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.