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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06307665 | Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma | PHASE3 | RECRUITING | 440 | — | — | May 20, 2024 | Oct 13, 2027 | Jun 4, 2026 | 140 | United States, China +2 |
The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Budesonide/albuterol metered -dose inhaler (BDA MDI) | EXPERIMENTAL | Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed. |
| Albuterol sulfate metered-dose inhaler (AS MDI) | ACTIVE_COMPARATOR | Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed. |
| Name | Type | Description |
|---|---|---|
| BDA MDI | COMBINATION_PRODUCT | Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed. |
| AS MDI | COMBINATION_PRODUCT | Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed. |
Inclusion Criteria: * Confirmed clinical diagnosis of asthma at least 12 months. * Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month 1. Low-to-high-dose Inhaled corticosteroid(s) (ICS) 2. Low-to-high-d...