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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00723021 | PF-04191834 Single Dose Bronchodilatory Study In Asthma. | PHASE2 | COMPLETED | 15 | — | — | Jul 1, 2008 | Jul 1, 2009 | Feb 1, 2013 | 4 | United States |
The FEV1 is the maximal volume of air that can be forcefully exhaled in one second
| Arm | Type | Description |
|---|---|---|
| PF-04191834 30mg | EXPERIMENTAL | - |
| PF-04191834 100mg | EXPERIMENTAL | - |
| PF-04191834 2000mg | EXPERIMENTAL | - |
| zileuton | ACTIVE_COMPARATOR | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-04191834 | DRUG | 30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets. |
| zileuton | DRUG | 1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose. |
| Placebo | DRUG | 2 x placebo tablets + placebo oral dispersion, single dose. |
Inclusion Criteria: * Persistent mild/moderate asthma for at least 6 months. * Reduced lung function * Reversible airway obstruction Exclusion Criteria: * Pregnant/nursing females. * Liver function tests greater than upper limit of normal (ULN)