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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_565 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Active Comparator | Fluticasone 440 mcg |
|
| 3 | Active Comparator | Fluticasone 1980 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sputum percent neutrophils | 6 hours following inhaled LPS challenge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Comparator: Placebo to fluticasone | Drug | Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods |
|
| Comparator: Lipopolysaccharide (LPS) | Drug | 20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods |
|
| Comparator: albuterol | Drug | 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. |
|
| 6 hours following inhaled LPS challenge |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |