Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Albuterol DPI/inh · 1 trial · 1 indication
Serial FEV1 measurements to demonstrate the mean AUC change in percent FEV1 from same-day baseline of A006 versus placebo control
| Arm | Type | Description |
|---|---|---|
| T1 | EXPERIMENTAL | Two inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg |
| T2 | EXPERIMENTAL | Two inhalations of Albuterol DPI 25 mcg/inh; Total Albuterol dose of 50 mcg |
| T3 | EXPERIMENTAL | Two inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg |
| T4 | EXPERIMENTAL | Two inhalations of Albuterol DPI 90 mcg/inh; Total Albuterol dose of 180 mcg |
| P | PLACEBO_COMPARATOR | Two inhalations Placebo DPI; Total Albuterol dose of 0 mcg |
| R1 | ACTIVE_COMPARATOR | One inhalation of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 90 mcg |
| R2 | ACTIVE_COMPARATOR | Two inhalations of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 180 mcg |
| Name | Type | Description |
|---|---|---|
| Albuterol DPI 25 mcg/inh | DRUG | Albuterol DPI with 25 mcg Albuterol/inhalation |
| Albuterol DPI 90 mcg/inh | DRUG | Albuterol DPI with 90 mcg Albuterol/inhalation |
| Placebo DPI | DRUG | Placebo DPI with 0 mcg Albuterol/inhalation |
| Albuterol MDI 90 mcg/inh | DRUG | Albuterol MDI with 90 mcg Albtuerol/inhalation |
Inclusion Criteria: * Generally healthy, male and female adults, 18-55 years of age at screening * With mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler * Demonstrate a Forced Expiratory Volume (FEV1) at 50-85 percent of predicted...