Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01136655 | A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy | PHASE2 | COMPLETED | 54 | — | — | Sep 1, 2010 | Dec 1, 2011 | Oct 31, 2013 | 34 | United States, Bulgaria +4 |
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...