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Momat Rhino Advance · 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...
Momat Rhino Advance is an investigational small molecule nasal spray developed by Novartis AG (ticker NVS) for seasonal allergic rhinitis. It is a fixed-dose combination product containing azelastine 140 mcg and mometasone 50 mcg, delivered as a nasal spray. The drug is in Phase 3 clinical development.
Momat Rhino Advance is being developed for the treatment of seasonal allergic rhinitis in adults. It is intended for patients aged 18 years and older. The condition studied in its clinical program is seasonal allergic rhinitis, a respiratory therapeutic area indication.
Momat Rhino Advance is developed by Novartis AG, which trades under the ticker NVS. The product is manufactured by Glenmark, India, according to the trial description. Novartis is the sponsor of the clinical development program for this asset.
Momat Rhino Advance is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The drug has not been approved by the FDA and remains investigational for seasonal allergic rhinitis.
Momat Rhino Advance has been evaluated in one completed Phase 3 trial, NCT05590598. The trial enrolled 472 patients with seasonal allergic rhinitis in Russia. It was randomized, double-blind, and active-controlled, comparing Momat Rhino Advance nasal spray 140 mcg plus 50 mcg against another azelastine plus mometasone nasal spray as monotherapy.