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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03879837 | Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg | PHASE3 | COMPLETED | 1,902 | — | — | Mar 25, 2019 | Jul 9, 2021 | Sep 1, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Fluticasone propionate pressurized metered dose inhaler, 110 mcg per actuation |
| Reference Listed Drug | ACTIVE_COMPARATOR | Flovent HFA pressurized metered dose inhaler, 110 mcg per actuation |
| Placebo | PLACEBO_COMPARATOR | Placebo pressurized metered dose inhaler, no active content |
| Name | Type | Description |
|---|---|---|
| Fluticasone propionate pressurized metered dose inhaler | DRUG | 110 mcg per actuation |
| Flovent HFA pressurized metered dose inhaler | DRUG | 110 mcg per actuation |
| Placebo pressurized metered dose inhaler | DRUG | no active content |
Inclusion Criteria: 1. Adult ≥18 and ≤75 years of age male or female subjects of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control. 2. Body mass index (BMI) ≥18 and ≤45. 3. Diagnosis of asthma, as defined by t...