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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00839800 | Study to Investigate the Efficacy of Symbicort® SMART. | PHASE3 | COMPLETED | 2,091 | — | — | Feb 1, 2009 | Feb 1, 2011 | Nov 30, 2012 | 109 | Argentina, Brazil +10 |
| NCT00837967 | Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients | PHASE3 | COMPLETED | 25 | — | — | Jan 1, 2009 | Jul 1, 2009 | Aug 29, 2012 | 2 | Japan |
Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment.
Total number of adverse events
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed |
| 2 | ACTIVE_COMPARATOR | Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed |
| First Symbicort, then Terbutaline | EXPERIMENTAL | Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days |
| First Turbuhaler, then Symbicort | EXPERIMENTAL | Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days, |
| Name | Type | Description |
|---|---|---|
| Symbicort Turbuhaler | DRUG | 160/4.5 µg |
| Terbutaline Turbuhaler | DRUG | 0.4 mg |
Inclusion Criteria: * Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration. * Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inha...