Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...