Study of Biomarkers of Airway Inflammation (0000-128)

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Albuterol; Fluticasone; Xhance

Criteria

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