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Mometasone · 1 trial · 1 indication
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 ...
Mometasone is used for the treatment of Seasonal Allergic Rhinitis, a condition commonly known as hay fever. It is being developed as a small molecule therapy for this respiratory condition. The drug is currently in Phase 3 clinical development, meaning it is still investigational and has not yet been approved for use.
Mometasone is being developed by Novartis AG, a global pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of Mometasone for the treatment of Seasonal Allergic Rhinitis.
Mometasone is in Phase 3 clinical development. This is the final stage of testing before a potential regulatory submission. The drug is being studied for Seasonal Allergic Rhinitis, and it is currently investigational, meaning it has not been approved by regulatory authorities. One Phase 3 trial has been completed.
Mometasone has been studied in a Phase 3 clinical trial with the identifier NCT05311475. This was a prospective, randomized, multinational, multicenter, double-blind, placebo and active controlled trial with four parallel groups. The trial enrolled 669 patients with Seasonal Allergic Rhinitis and was conducted in Bulgaria, Germany, Moldova, and Poland.
Mometasone is a corticosteroid medication used to treat Seasonal Allergic Rhinitis. It is being developed by Novartis AG. The drug is in Phase 3 clinical trials, and the completed study NCT05311475 evaluated its effects in 669 patients. The trial was randomized, double-blind, and placebo-controlled.