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Study of Biomarkers of Airway Inflammation (0000-128)

NCT00869596 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-07-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-09-30
Completion
2009-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00869596 on ClinicalTrials.gov