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Azelastine, Fluticasone · 3 trials · 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
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 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
Azelastine, Fluticasone is a fixed-dose combination nasal spray used for the treatment of allergic rhinitis. It combines the antihistamine azelastine with the corticosteroid fluticasone to address nasal allergy symptoms. The drug is being developed by Viatris Inc. and is currently in Phase 3 clinical development for this indication.
Azelastine, Fluticasone combines two active ingredients: azelastine, an antihistamine that blocks histamine H1 receptors, and fluticasone, a corticosteroid that reduces inflammation. Together they target the allergic response in the nasal passages to relieve symptoms of allergic rhinitis.
Azelastine, Fluticasone is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting clinical trials for this fixed-dose combination nasal spray intended for the treatment of allergic rhinitis.
Azelastine, Fluticasone is in Phase 3 clinical development for allergic rhinitis. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial, NCT03599791, enrolled 900 patients in China and has been completed.
Azelastine, Fluticasone has completed three clinical trials. Two Phase 1 pharmacokinetic studies, NCT01190852 and NCT01194622, enrolled 30 healthy volunteers each in Germany. A Phase 3 study, NCT03599791, enrolled 900 patients with allergic rhinitis in China. All trials are completed.
Azelastine, Fluticasone is the fixed-dose combination known by the brand name Dymista. The Phase 3 trial NCT03599791 is titled 'DYmista NAsal Spray in CHInese Patients,' confirming that the combination of azelastine and fluticasone is marketed as Dymista.