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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01460511 | Evaluation of Efficacy and Safety of E004 in Children With Asthma | PHASE3 | COMPLETED | 70 | — | — | Oct 1, 2011 | Jul 1, 2012 | Jul 31, 2018 | 8 | United States |
bronchodilator effect expressed as AUC of FEV1's relative change (from the same day baseline) versus time, defined as AUC of ΔFEV1%.
| Arm | Type | Description |
|---|---|---|
| P - Placebo-HFA | PLACEBO_COMPARATOR | Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
| T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI | EXPERIMENTAL | E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
| Name | Type | Description |
|---|---|---|
| E004 (Epinephrine Inhalation Aerosol) HFA-MDI | DRUG | E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
| Placebo-HFA | DRUG | Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
Inclusion Criteria: * Generally healthy male, and premenarchal female, children aged 4 - 11 years upon Screening. * With documented asthma, requiring inhaled epinephrine or beta2-agonist treatment, with or without concurrent anti-inflammatory therapies for at least 6-months prior to Screening. * Be...