Study of Biomarkers of Airway Inflammation (0000-128)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Airway Inflammation

Treatments: Drug: Comparator: albuterol; Drug: Comparator: Lipopolysaccharide (LPS); Drug: fluticasone propionate; Drug: Comparator: Placebo to fluticasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00869596

0000-128

2009_565

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo to fluticasone

Drug: Comparator: Lipopolysaccharide (LPS)

Drug: Comparator: albuterol

2

Active Comparator group

Description:

Fluticasone 440 mcg

Treatment:

Drug: fluticasone propionate

Drug: Comparator: Lipopolysaccharide (LPS)

Drug: Comparator: albuterol

3

Active Comparator group

Description:

Fluticasone 1980 mcg

Treatment:

Drug: fluticasone propionate

Drug: Comparator: Lipopolysaccharide (LPS)

Drug: Comparator: albuterol