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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01018030 | Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis | PHASE2 | COMPLETED | 741 | — | — | Jan 6, 2010 | Jul 16, 2010 | May 17, 2017 | 87 | Bulgaria, Canada +10 |
The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization).
| Arm | Type | Description |
|---|---|---|
| FFNS 110 mcg QD | EXPERIMENTAL | - |
| FFNS 110 mcg BID | EXPERIMENTAL | - |
| Placebo Nasal Spray | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| FFNS 110 mcg QD | DRUG | Active Nasal Spray (AM) and Placebo Nasal Spray (PM) |
| FFNS 110 mcg BID | DRUG | Active Nasal Spray (AM) and Active Nasal Spray (PM) |
| Placebo Nasal Spray | DRUG | Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM) |
Inclusion Criteria: 1. Informed consent 2. Outpatient 3. Age (\>= 18 years at Visit 1 for Russia, Ukraine, and Germany; \>= 12 years at Visit 2 for all other countries) 4. Diagnosis of uncomplicated acute rhinosinusitis 5. Ability and willingness to comply with study procedures and restrictions. 6....