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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00855959 | Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients | PHASE3 | COMPLETED | 108 | — | — | Feb 1, 2009 | Aug 1, 2009 | Mar 11, 2011 | 6 | Japan |
Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Four weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily |
| 2 | EXPERIMENTAL | Pulmicort Turbuhaler at a dose of 200 μg twice daily and Pulmicort Respules at a dose of 0.5 mg twice daily or 1.0 mg once daily (low dose) |
| Name | Type | Description |
|---|---|---|
| Budesonide | DRUG | Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks |
| Pulmicort Turbuhaler | DRUG | Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler |
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * A minimum of 6 months documented history of asthma according to the JGL 2006 definition * Asthma patients under prescribed treatment with ICS at least 3 months before Visit 2. Exclusion Criteria: * Curre...