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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01737905 | Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma | PHASE3 | COMPLETED | 28 | — | — | Oct 1, 2012 | Dec 1, 2013 | Mar 11, 2016 | 6 | United States |
Bronchodilator effect expressed as AUC of FEV1's relative change from the same day baseline (pre-dose) versus time up to 3 hours, defined as AUC(0-3) of change in FEV1%. The difference of primary endpoints of E004 and Placebo will be evaluated statistically.
| Arm | Type | Description |
|---|---|---|
| Arm T | EXPERIMENTAL | Experimental arm utilizing Epinephrine HFA-MDI (E004) |
| Arm P | PLACEBO_COMPARATOR | Placebo comparator arm utilizing Placebo-HFA |
| Name | Type | Description |
|---|---|---|
| Epinephrine HFA-MDI (E004) | DRUG | Single dose 125 mcg/inhalation, 2 inhalations |
| Placebo-HFA | DRUG | Single dose 0 mcg/inhalation, 2 inhalations |
Inclusion Criteria: * Generally healthy male, and premenarchal female, children ages 4 - 11 years upon Screening. * With documented asthma, requiring inhaled epinephrine or β2-agonist treatment, with or without concurrent anti-inflammatory therapies including orally inhaled corticosteroids, for at ...