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Azelastine+ Mometazone · 1 trial · 1 indication
r-TNSS (reflective Total Nasal Symptom Score) consists of 4 symptom scores (Nasal congestion, Runny nose, Itchy nose, Sneezing), each of which can be scored on a 4-point scale (0-3). Higher scores mean a more severe symptom. By its nature, the total index r-TNSS is a rank indicator, it is an integer from the range from 0 to 12 points. As a working indicator, the average between the morning and evening values is used. As a measure of the effect of the drug, the change in the index relative to the initial value is used. Baseline is defined as the average r-TNSS score over three days of the Run-in period (2 morning (AM) and 3 evening (PM)) plus morning measurements of study day 1 (assessment in the morning prior to first administration).
| Arm | Type | Description |
|---|---|---|
| Group 1: Azelastine + Mometasone, nasal spray | EXPERIMENTAL | Participants will receive test product Azelastine + Mometasone, nasal spray, 140 mcg + 50 mcg/dose (Sandoz d.d., Slovenia), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days. |
| Group 2: Momat Rhino Advance, nasal dosed spray | ACTIVE_COMPARATOR | Participants will receive reference product Momat Rhino Advance, nasal dosed spray, 140 mcg + 50 mcg mcg/dose (Glenmark Pharmaceuticals Limited., India), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days. |
| Name | Type | Description |
|---|---|---|
| Azelastine + Mometazone, nasal spray | COMBINATION_PRODUCT | 140 mcg + 50 mcg/dose (Sandoz d.d., Slovenia), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days. |
| Momat Rhino Advance | COMBINATION_PRODUCT | 140 µg + 50 µg/dose - one actuation into each nostril twice daily - morning and evening (interval between administrations is 12 hrs), corresponding to 560 µg/day of azelastine and 200 µg/day of mometasone for 14 consecutive days |
Inclusion Criteria: Patients meeting the following criteria will be included in the study and allocated to treatment groups: * 18 to 65 years old inclusive, male and female; * voluntarily signed informed consent for participation in this clinical study; * presence of confirmed moderate or severe s...
Azelastine + Mometasone is an investigational combination nasal spray being studied for the treatment of Seasonal Allergic Rhinitis. It combines two small molecule drugs, azelastine and mometasone, in a single formulation. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Azelastine + Mometasone combines an antihistamine and a corticosteroid. Azelastine works by blocking histamine receptors to reduce allergic symptoms, while mometasone reduces inflammation in the nasal passages. Together, they target the underlying allergic response and inflammation associated with Seasonal Allergic Rhinitis.
Azelastine + Mometasone is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is a combination nasal spray being evaluated for the treatment of Seasonal Allergic Rhinitis.
Azelastine + Mometasone is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The Phase 3 trial has been completed, and the drug is being evaluated for safety and efficacy in patients with Seasonal Allergic Rhinitis.
Azelastine + Mometasone has one completed Phase 3 clinical trial registered under NCT05590598. This randomized, double-blind, active-controlled study evaluated the efficacy and safety of the drug compared to a reference product in 472 patients with Seasonal Allergic Rhinitis. The trial was conducted in Russia and enrolled adults aged 18 years and older.
Azelastine + Mometasone is being studied as a potential generic equivalent to Momat Rino Advance, a nasal spray containing 140 mcg of azelastine and 50 mcg of mometasone. The Phase 3 trial compared the two formulations to assess whether they are therapeutically equivalent in treating Seasonal Allergic Rhinitis.