Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AS MDI 90 μg · 1 trial · 1 indication
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...
AS MDI 90 μg is an investigational small molecule being developed for the treatment of asthma. It is administered as a metered-dose inhaler (MDI) and is currently in Phase 2 clinical development. The drug is being studied in adult and adolescent patients with asthma.
AS MDI 90 μg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational asthma treatment.
AS MDI 90 μg is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its effects in patients with asthma.
AS MDI 90 μg has been studied in one completed Phase 2 clinical trial, identified as NCT03364608. This randomized, double-blind, placebo-controlled study enrolled 86 participants with asthma in the United States, including adolescents aged 12 years and older.
AS MDI 90 μg is also known as PT007. In clinical trials, it has been compared to placebo MDI and open-label Proventil HFA. The drug is being developed by AstraZeneca for the treatment of asthma.