Study of Biomarkers of Airway Inflammation (0000-128)

Phase 1

Completed

• Conditions: Airway Inflammation
• Interventions: Drug: fluticasone propionate

• Registration Number: NCT00869596
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study
• Male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study
• Subject is a nonsmoker
• Subject is in generally good health
• Subject is willing to comply with the diet, alcohol, and caffeine study restrictions

Exclusion Criteria

• Subject is a nursing mother
• Subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening
• Subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection
• Subject has a recent history of allergic rhinitis at screening
• Subject has any respiratory disease at screening
• Subject has daily phlegm or a chronic cough
• Subject is unable to refrain from the use of any prescription or non-prescription drugs or herbal remedies during the study
• Subject consumes excessive amounts of alcohol or caffeine
• Subject has had major surgery, or donated or lost 1 unit of blood within 4 weeks of screening
• Subject has a history of stroke, seizures, or major neurological disorders
• Subject regularly uses illicit drugs or has a history of drug/alcohol abuse
• Subject received a vaccination within 3 weeks of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	fluticasone propionate	Fluticasone 440 mcg
3	fluticasone propionate	Fluticasone 1980 mcg

Primary Outcome Measures

Name	Time	Method
Sputum percent neutrophils	6 hours following inhaled LPS challenge

Secondary Outcome Measures

Name	Time	Method
Sputum absolute neutrophils (per mL)	6 hours following inhaled LPS challenge
Sputum levels of IL1beta and IL8	6 hours following inhaled LPS challenge
Sputum mRNA expression levels of CD14 and IL1beta	6 hours following inhaled LPS challenge