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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...
Top 1 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150 |
Azelastine Hydrochl./Fluticasone Prop. 0.137/ACTUAT is an investigational combination nasal spray being developed for allergic rhinitis. It combines an antihistamine and a corticosteroid in a single formulation. Viatris Inc. is developing it, and it has been studied in a Phase 3 trial in Chinese patients aged 12 years and older.
The azelastine component of Azelastine Hydrochl./Fluticasone Prop. 0.137/ACTUAT targets the HRH1 histamine receptor as an antagonist. By blocking HRH1, azelastine reduces histamine-driven allergic symptoms. The fluticasone propionate component is a corticosteroid that addresses the inflammatory component of allergic rhinitis. Together they provide antihistamine and anti-inflammatory activity in one nasal spray.
Viatris Inc. (ticker VTRS) is developing Azelastine Hydrochl./Fluticasone Prop. 0.137/ACTUAT. The company is studying the fixed-dose combination nasal spray for allergic rhinitis. Viatris is the sponsor of the clinical program, which includes a completed Phase 3 trial conducted in China.
Azelastine Hydrochl./Fluticasone Prop. 0.137/ACTUAT is in Phase 3 development. It is an investigational product and has not been approved by the FDA. The program includes one completed Phase 3 trial with 900 participants. No active trials are currently listed for this asset.
Azelastine Hydrochl./Fluticasone Prop. 0.137/ACTUAT has been studied in one Phase 3 trial, NCT03599791, titled DYmista NAsal Spray in CHInese Patients. The trial enrolled 900 participants with allergic rhinitis in China, was randomized, double-blind, and active-controlled, and included patients aged 12 years and older. It is now completed.