Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2009-03-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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1
Placebo
Comparator: Placebo to fluticasone
Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
Comparator: Lipopolysaccharide (LPS)
20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
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.
2
Fluticasone 440 mcg
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
Comparator: Lipopolysaccharide (LPS)
20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
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.
3
Fluticasone 1980 mcg
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
Comparator: Lipopolysaccharide (LPS)
20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
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.
Interventions
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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
Comparator: Placebo to fluticasone
Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
Comparator: Lipopolysaccharide (LPS)
20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
50 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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2009_565
Identifier Type: -
Identifier Source: secondary_id
0000-128
Identifier Type: -
Identifier Source: org_study_id
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