Status:
COMPLETED
Study of Biomarkers of Airway Inflammation (0000-128)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Airway Inflammation
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00869596
Start Date
March 1 2009
End Date
September 1 2009
Last Update
July 23 2015
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