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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03599791 | DYmista NAsal Spray in CHInese Patients | PHASE3 | COMPLETED | 900 | — | — | Jun 29, 2018 | Sep 24, 2019 | Feb 22, 2022 | 33 | China |
| NCT01190852 | Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays | PHASE1 | COMPLETED | 30 | — | — | Aug 1, 2010 | Oct 1, 2010 | Feb 7, 2022 | 1 | Germany |
| NCT01194622 | Single Dose Pharmacokinetics of Intranasal Fluticasone Delivered by a Fixed Combination With Azelastine (MP29 02) in Comparison to Two Different Fluticasone Nasal Sprays | PHASE1 | COMPLETED | 30 | — | — | Aug 1, 2010 | Oct 1, 2010 | Feb 7, 2022 | 1 | Germany |
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
Effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE alone; REF).
Effect of azelastine hydrochloride (AZE) on the relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE (i.e. FLU alone in the MP29-02 vehicle; REF).
| 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. |
| Azelastine, Fluticasone | EXPERIMENTAL | TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray |
| Azelastine mono | ACTIVE_COMPARATOR | REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies) |
| Azelastine | ACTIVE_COMPARATOR | COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product) |
| Fluticasone mono | ACTIVE_COMPARATOR | REF = FLU mono Fluticasone Propionate nasal spray (= essentially combination product formulation without any AZE; US FLU mono formulation as used in pivotal studies) |
| Fluticasone | ACTIVE_COMPARATOR | COMP = Fluticasone Propionate Nasal Spray, Roxane Laboratories = FLU mono Fluticasone propionate nasal spray (= US marketed product) |
| 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 |
| Azelastine, Fluticasone | DRUG | TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray |
| Azelastine mono | DRUG | REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies) |
| Azelastine | DRUG | COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product) |
| Fluticasone mono | DRUG | REF = FLU mono Fluticasone Propionate nasal spray (= essentially combination product formulation without any AZE; US FLU mono formulation as used in pivotal studies) |
| Fluticasone | DRUG | COMP = Fluticasone Propionate Nasal Spray, Roxane Laboratories = FLU mono Fluticasone propionate nasal spray (= US marketed product) |
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 | NA | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | — | Undisclosed |