Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
80/2.25 μg Symbicort pMDI · 1 trial · 1 indication
Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value is expressed in liters. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.
| Arm | Type | Description |
|---|---|---|
| BUD 160/FM 2.25 | EXPERIMENTAL | 2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations |
| BUD 160/FM 4.5 | EXPERIMENTAL | placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations) |
| BUD 160/FM 9.0 | EXPERIMENTAL | placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations) |
| BUD 160 | PLACEBO_COMPARATOR | placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations |
| BUD 160/Foradil 12.0 | ACTIVE_COMPARATOR | Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations |
| Name | Type | Description |
|---|---|---|
| 80/2.25 μg Symbicort pMDI | DRUG | inhalation |
| 80/4.5 μg Symbicort pMDI | DRUG | inhalation |
| Foradil Aerolizer 12 μg | DRUG | inhalation |
| 40 μg budesonide HFA pMDI | DRUG | inhalation |
| placebo HFA pMDI | DRUG | inhalation |
Inclusion Criteria: * Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 1 * Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting β2-agonist of =60% and =8...
80/2.25 μg Symbicort pMDI is an investigational small molecule being studied for the treatment of asthma. It is a pressurized metered-dose inhaler formulation containing 80 μg of budesonide and 2.25 μg of formoterol. The drug is currently in Phase 2 clinical development for asthma.
80/2.25 μg Symbicort pMDI is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical research on this formulation for the treatment of asthma.
80/2.25 μg Symbicort pMDI is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial for this formulation has been completed.
80/2.25 μg Symbicort pMDI has one completed clinical trial, registered as NCT01136655. This Phase 2 study evaluated single doses of formoterol and Foradil in asthmatic children aged 6 to less than 12 years. The trial enrolled 54 participants across the United States, Bulgaria, Czechia, Hungary, Poland, and South Africa.
80/2.25 μg Symbicort pMDI is a specific formulation of Symbicort, which is a combination inhaler containing budesonide and formoterol. This particular strength and delivery form is being studied for asthma. The drug is developed by AstraZeneca and is currently in Phase 2 clinical trials.