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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02091986 | A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg | PHASE3 | COMPLETED | 882 | — | — | Apr 1, 2014 | Apr 1, 2016 | Apr 10, 2017 | 70 | United States, Mexico +2 |
| NCT01444430 | A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents | PHASE3 | COMPLETED | 12,460 | — | — | Dec 1, 2011 | Oct 1, 2015 | Dec 15, 2016 | 340 | United States, Argentina +24 |
| NCT00651768 | Titratable Dosing in Moderate to Severe Asthmatics | PHASE3 | COMPLETED | 570 | — | — | Aug 1, 2003 | Jan 1, 2005 | Jan 24, 2011 | - | — |
1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
| Arm | Type | Description |
|---|---|---|
| Symbicort pMDI 80/2.25 µg | ACTIVE_COMPARATOR | Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily |
| Symbicort pMDI 80/4.5µg | ACTIVE_COMPARATOR | Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily |
| Budesonide pMDI | ACTIVE_COMPARATOR | Budesonide pMDI 80µg, 2 acuations twice daily |
| 1 | EXPERIMENTAL | Symbicort |
| 2 | ACTIVE_COMPARATOR | budesonide |
| Name | Type | Description |
|---|---|---|
| Symbicort pMDI | DRUG | Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily |
| Budesonide pMDI | OTHER | Budesonide pMDI 80µg, 2 acuations twice daily |
| budesonide/formoterol | DRUG | - |
| Symbicort pMDI + budesonide HFA pMDI | DRUG | Symbicort 2 X 160/4.5mcg \& budesonide HFA pMDI 4 X 160mcg |
Inclusion Criteria: * Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2 * Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to...