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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03364608 | Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma | PHASE2 | COMPLETED | 86 | — | — | Dec 15, 2017 | Mar 30, 2018 | Jul 24, 2019 | 10 | United States |
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
| Arm | Type | Description |
|---|---|---|
| • AS MDI 90 µg | EXPERIMENTAL | (2 actuations of 45 µg/actuation) |
| • AS MDI 180 µg | EXPERIMENTAL | (2 actuations of 90 µg/actuation) |
| • Placebo MDI | PLACEBO_COMPARATOR | (2 actuations) |
| • Proventil 90 µg | ACTIVE_COMPARATOR | (1 actuation of 90 µg/actuation) |
| • Proventil 180 µg | ACTIVE_COMPARATOR | (2 actuations of 90 µg/actuation) |
| Name | Type | Description |
|---|---|---|
| AS MDI 90 μg | DRUG | AS MDI 90 μg (2 actuations of 45 μg/actuation) |
| AS MDI 180 µg | DRUG | AS MDI 180 μg (2 actuations of 90 μg/actuation) |
| Placebo MDI | OTHER | Placebo MDI (2 actuations) |
| Proventil 90 μg | DRUG | Proventil 90 μg (1 actuation of 90 μg/actuation) |
| Proventil 180 μg | DRUG | Proventil 180 μg (2 actuations of 90 μg/actuation) |
Inclusion Criteria * Are at least 12 years of age and no older than 65 years * 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; On...