Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Intervention: AS MDI · 1 trial · 1 indication
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. Area Under the Curve (AUC) 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Change from baseline in FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
| 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...
AS MDI is an investigational inhaled small molecule being studied for the treatment of asthma. It is delivered via a metered dose inhaler and is being evaluated for its effect on lung function in adult participants with asthma. The drug is currently in Phase 2 clinical development.
AS MDI is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.
AS MDI is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. A Phase 2 trial evaluating the drug in adult participants with asthma has been completed.
AS MDI has one completed Phase 2 clinical trial, identified as NCT06644924. This study evaluated the effect of inhaled AS MDI versus placebo and Ventolin Evohaler on lung function in 118 adult participants with asthma in the United States. The trial was randomized, double-blind, and controlled.
Yes, AS MDI is also known as PT007. The clinical trial NCT06644924 refers to the drug as inhaled PT007 (AS MDI), indicating that both names refer to the same investigational product being developed by AstraZeneca for the treatment of asthma.