Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azelastine Hydrochl./Fluticasone Prop. 0.137/ACTUAT · 1 trial · 1 indication
Total nasal symptom score (TNSSS) is a sum of 4 individual nasal symptom scores: nasal itching, runny nose, congestion and sneezing. Each nasal symptom will be assessed according to a 4-ponit scale (0 = no, 1 = mild, 2 = moderate, 3 = severe symptom); thus, each TNSS will be in the range from 0 (no symptoms at all) to 12 (all 4 symptoms are severe) and the combined 12-hour reflective TNSS (morning + evening) will be in the range of 0 to 24 accordingly
| Arm | Type | Description |
|---|---|---|
| Azelastine Hydrochl. + Fluticasone Prop. | EXPERIMENTAL | Drug: Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT Nasal Spray, consists of a fixed-dose combination of azelastine hydrochloride and fluticasone propionate; 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo. |
| Azelastine hydrochloride | ACTIVE_COMPARATOR | Drug: Azelastine Hydrochloride 0.137 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo. |
| Fluticasone propionate | ACTIVE_COMPARATOR | Drug: Fluticasone Propionate 0.05 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo. |
| Name | Type | Description |
|---|---|---|
| Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT | DRUG | Dymista Nasal spray suspension |
| Azelastine Hydrochloride 0.137 MG/ACTUAT | DRUG | AZEP Nasal spray solution |
| Fluticasone Propionate 0.05 MG/ACTUAT | DRUG | Fluticasone propionate nasal spray suspension |
General Inclusion Criteria: To be eligible for enrolment into this study, a patient must comply with all of the following criteria: 1. Male or female patient 12 years of age or older. 2. Provide written informed consent. 3. Patients must have moderate-to-severe rhinitis or rhinoconjunctivitis, def...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |