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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01476904 | Safety Study in Adolescent and Adult Patients With Asthma | PHASE3 | COMPLETED | 208 | — | — | Nov 1, 2011 | Jul 1, 2012 | Feb 13, 2017 | 27 | United States |
Recording of all adverse events experienced during the course of the study
| Arm | Type | Description |
|---|---|---|
| Arm T | EXPERIMENTAL | Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals |
| Arm P | PLACEBO_COMPARATOR | Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals |
| Arm A | ACTIVE_COMPARATOR | Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 0 mcg/inhalation, 2 inhalations QID |
| Primatene Mist | DRUG | 220 mcg/inhalation, 2 inhalations QID |
| Epinephrine inhalation | DRUG | 125 mcg/inhalation, 2 inhalations QID |
Inclusion Criteria: * Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation * Male and female asthma patients aged 12 - 75 years * Patients with documented ...