Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BDA MDI
Albuterol/budesonide · 1 trial · 1 indication
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...