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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02680561 | A Double Blind Open Label Comparator Study to Compare Treatments in 4 to 11 Year Old Patients With Asthma | PHASE1 | COMPLETED | 20 | — | — | Apr 1, 2016 | Aug 1, 2016 | Nov 9, 2021 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Treatment A: Fp MDPI | EXPERIMENTAL | Single inhalation dose of Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) on Day 1 into 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, BAC, or CBA) |
| Treatment B: FS MDPI | EXPERIMENTAL | Single inhalation dose of Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) on Day 1 into 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, BAC, or CBA) |
| Treatment C: Comparator | ACTIVE_COMPARATOR | Single inhalation dose of fluticasone propionate/salmeterol (ADVAIR DISKUS) on Day 1 into 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, BAC, or CBA) |
| Name | Type | Description |
|---|---|---|
| Fluticasone Propionate MDPI | DRUG | - |
| Fluticasone Propionate/Salmeterol MDPI | DRUG | - |
| Fluticasone propionate/salmeterol | DRUG | - |
Inclusion Criteria: * The patient is a male or female aged 4 through 11 years of age, inclusive * Severity of disease: The patient has persistent asthma * Asthma diagnosis: The patient has a diagnosis of asthma as defined by the NIH. * The patient has required less than 4 inhalations per week of re...