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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03371459 | Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma | PHASE2 | COMPLETED | 46 | — | — | Dec 29, 2017 | Mar 26, 2018 | Jul 23, 2019 | 5 | United States |
Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
| Arm | Type | Description |
|---|---|---|
| AS MDI | EXPERIMENTAL | AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation |
| Proventil | ACTIVE_COMPARATOR | Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation |
| Name | Type | Description |
|---|---|---|
| AS MDI | DRUG | AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation |
| Proventil | DRUG | Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation |
Inclusion Criteria: * Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis * Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to me...