Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05311475 | Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis | PHASE3 | COMPLETED | 669 | — | — | Apr 4, 2022 | Jun 20, 2023 | Jul 11, 2023 | 28 | Bulgaria, Germany +2 |
The benefit of the treatment with the fixed combination medicinal product Momeatsone+Azelastine nasal spray (test product) in comparison to the treatment with the individual medicinal products Mometasone nasal spray and Azelastine nasal spray (comparator products) will be assessed by comparing the change from baseline in the daily Total Nasal Symptom Score (TNSS) during the first seven days of treatment. Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary. Each symptom will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms, such that the maximum TNSS is 12.
| Arm | Type | Description |
|---|---|---|
| Mometasone + Azelastine | EXPERIMENTAL | Mometasone + Azelastine (50 + 140 mcg per actuation) |
| Mometasone | ACTIVE_COMPARATOR | Mometasone furoate nasal spray (50 mcg per actuation) |
| Azelastine | ACTIVE_COMPARATOR | Azelastine hydrochloride nasal spray (140 mcg per actuation) |
| Placebo | PLACEBO_COMPARATOR | Placebo nasal spray |
| Name | Type | Description |
|---|---|---|
| Mometasone | DRUG | Mometasone furoate nasal spray (50 mcg per actuation) |
| Azelastine | DRUG | Azelastine hydrochloride nasal spray (140 mcg per actuation) |
| Placebo | DRUG | Placebo nasal spray |
Inclusion Criteria: Only patients fulfilling all of the following criteria at screening Visit 1 should be included in the present trial: * Male or non-pregnant, non-lactating female patient aged between 12 and 65 years (valid for Poland) OR between 18 and 65 years (valid for Bulgaria, Moldova and ...