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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06644924 | A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With Asthma | PHASE2 | COMPLETED | 118 | — | — | Feb 10, 2025 | Jun 4, 2025 | Sep 3, 2025 | 22 | United States |
Change from baseline FEV1 measured at each time point. Baseline FEV1 is the period specific mean of the available pre-dose values. Area Under the Curve (AUC) is calculated for the available time points using the trapezoidal rule.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment A (Ventolin Evohaler) , Treatment B (Placebo MDI), and Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007). |
| Treatment Sequence 2 | EXPERIMENTAL | Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007), Treatment A (Ventolin Evohaler) and Treatment B (Placebo MDI). |
| Treatment Sequence 3 | EXPERIMENTAL | Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment B (Placebo MDI), Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007), Treatment A (Ventolin Evohaler). |
| Treatment Sequence 4 | EXPERIMENTAL | Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007), Treatment B (Placebo MDI), Treatment A (Ventolin Evohaler). |
| Treatment Sequence 5 | EXPERIMENTAL | Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment B (Placebo MDI), Treatment A (Ventolin Evohaler), and Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007). |
| Treatment Sequence 6 | EXPERIMENTAL | Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment A (Ventolin Evohaler), Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007) and Treatment B (Placebo MDI). |
| Name | Type | Description |
|---|---|---|
| Intervention: AS MDI | COMBINATION_PRODUCT | Drug Treatment: (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007) Randomized participants will receive a single-dose (2 inhalations) |
| Intervention: Ventolin Evohaler | COMBINATION_PRODUCT | Drug: Treatment (Ventolin Evohaler) Randomized participants will receive a single-dose (2 inhalations) |
| Intervention: Placebo matching AS MDI | COMBINATION_PRODUCT | Drug: Treatment (Placebo MDI) Randomized participants will receive a single-dose (2 inhalations to match AS MDI) |
Inclusion Criteria: Age 1. Participant must be aged 18 to 65 years (inclusive), at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Participants should have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1. 3. Must be re...