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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00448435 | Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma | PHASE3 | COMPLETED | 51 | — | — | Apr 1, 2007 | Jan 1, 2008 | Jun 8, 2010 | 8 | Japan |
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \[Weeks 1-4/Weeks 7-10\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period \[Weeks 1-4/Weeks 7-10\]).
| Arm | Type | Description |
|---|---|---|
| SLM+FP First | ACTIVE_COMPARATOR | SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period). |
| SFC First | ACTIVE_COMPARATOR | SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period). |
| SFC | EXPERIMENTAL | SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period). |
| Name | Type | Description |
|---|---|---|
| GW815SF HFA MDI | DRUG | salmeterol and fluticasone propionate combination |
| salmeterol and fluticasone propionate | DRUG | salmeterol + fluticasone propionate |
Inclusion criteria: * Inclusion Criteria for Entry in Run-in Period A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study: * Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing po...