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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00509028 | Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma | PHASE3 | COMPLETED | 241 | — | — | Dec 1, 2006 | Oct 1, 2008 | Aug 27, 2012 | 1 | Japan |
AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.
| Arm | Type | Description |
|---|---|---|
| BUD - Budesonide | EXPERIMENTAL | Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily |
| CONV - Conventional Asthma Therapy | ACTIVE_COMPARATOR | Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
| Name | Type | Description |
|---|---|---|
| Budesonide | DRUG | Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily |
| Conventional Asthma Therapy | DRUG | According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
Inclusion Criteria: * Patient who complete preceding the Phase III study and provide a signed written informed consent by patient's legal representative at Visit 1 or 4 weeks prior to Visit 1 of the study. A signed written informed assent should also be obtained from the patients themselves as much...