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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01817790 | Assessment of Fluticasone Propionate on Ocular Allergy Symptoms | PHASE3 | COMPLETED | 626 | — | — | Dec 1, 2012 | Feb 1, 2013 | Apr 3, 2014 | 1 | United States |
| NCT00348361 | Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever) | PHASE1 | COMPLETED | 48 | — | — | Apr 1, 2005 | - | Oct 13, 2008 | 2 | Netherlands, United Kingdom |
The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.
| Arm | Type | Description |
|---|---|---|
| Fluticasone propionate nasal spray | EXPERIMENTAL | Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning. |
| Placebo nasal spray | PLACEBO_COMPARATOR | Two sprays of placebo per nostril to be administered in morning. |
| Name | Type | Description |
|---|---|---|
| Fluticasone propionate | DRUG | Nasal spray formulation (200 mcg/day) |
| Placebo | DRUG | Vehicle for Fluticasone propionate aqueous nasal spray |
Inclusion Criteria: 1. Participants with good general health (in the opinion of the investigator) with no clinically significant and relevant abnormalities of medical history 2. Participants with diagnosis of seasonal allergic rhinitis 1. A clinical history (written or verbal confirmation) of a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | NA | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | — | Undisclosed |