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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02266927 | A Study to Compare the Bioavailability Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2) | PHASE1 | COMPLETED | 28 | — | — | Sep 1, 2014 | Apr 1, 2015 | Feb 3, 2016 | 1 | Ireland |
Part 2
| Arm | Type | Description |
|---|---|---|
| Flovent® HFA 440µg | ACTIVE_COMPARATOR | Flovent® HFA (fluticasone propionate) Inhalation Aerosol 440 µg |
| OPTINOSE™ FLUTICASONE 400µg intranasal | EXPERIMENTAL | OPTINOSE™ FLUTICASONE, single dose of 400 µg intranasally |
| Name | Type | Description |
|---|---|---|
| Flovent HFA | DRUG | - |
| OPTINOSE™ FLUTICASONE | DRUG | - |
Inclusion Criteria: 1. Male or female subjects' ages 18 to 55 years, inclusive, at screening. 2. Have a body mass index of 18 to 32 kg/m2, inclusive, and a body weight of not less than 52 kg for males and 45 kg for females. 3. Otherwise healthy mild to moderate asthmatic (Part 2) with no clinically...