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Also known as MP29-02
Azelastine, Fluticasone · 2 trials · 1 indication
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, 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, 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) |
Inclusion Criteria: 1. Male or female healthy subjects of any Ethnic origin, age from 18 to 45 years. 2. Body mass index (BMI) from 18.5 to 30.0 kg/m2. 3. Use of adequate double contraception by female with childbearing potential (i.e. women of child bearing potential using a highly effective metho...
Top 1 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150 |
Azelastine and fluticasone is an intranasal fixed-combination product being developed for allergic rhinitis. It combines an antihistamine with a corticosteroid in a single nasal spray. Viatris Inc. (ticker VTRS) is the developer, and the program is in Phase 1 clinical development.
Azelastine and fluticasone targets HRH1, the histamine H1 receptor, which azelastine blocks as an antagonist. Fluticasone is a corticosteroid component of the fixed combination. The product is a small molecule formulation delivered intranasally for allergic rhinitis.
Viatris Inc., which trades under the ticker VTRS, is the developer of the azelastine and fluticasone fixed-combination nasal product. The company is responsible for the clinical development program in allergic rhinitis.
Azelastine and fluticasone is in Phase 1 clinical development. It is an investigational fixed-combination product and is not approved. Two Phase 1 trials have been completed, and no trials are currently active.
Two completed Phase 1 pharmacokinetic trials studied azelastine and fluticasone: NCT01194622, which compared intranasal fluticasone from the fixed combination with two fluticasone nasal sprays, and NCT01190852, which compared intranasal azelastine from the fixed combination with azelastine nasal sprays. Both enrolled 30 healthy volunteers in Germany.