Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00869596 | Study of Biomarkers of Airway Inflammation (0000-128) | PHASE1 | COMPLETED | 22 | — | — | Mar 1, 2009 | Sep 1, 2009 | Jul 23, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | Placebo |
| 2 | ACTIVE_COMPARATOR | Fluticasone 440 mcg |
| 3 | ACTIVE_COMPARATOR | Fluticasone 1980 mcg |
| Name | Type | Description |
|---|---|---|
| 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 |
| 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. |
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 ...