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Mometasone Furoate, 50 μg/act · 1 trial · 1 indication
The statistical analysis for both clinical equivalence and superiority of the active treatments over placebo will involve Analysis of Variance (ANOVA) and Analysis of Covariance (ANCOVA), respectively. The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence. The Intent-to-Treat Population (ITT) will be used for the primary analysis of superiority.
| Arm | Type | Description |
|---|---|---|
| Mometasone Furoate Monohydrate Nasal Spray,50 μg/act. | ACTIVE_COMPARATOR | Days 1 through 7, each subject received a placebo run-in. Days 8 through 21, 2 sprays (2 × 50 μg) of Mometasone Furoate Monohydrate Nasal Spray per nostril once daily for 14 days. Total Daily Dose = 4 × 50 μg = 200 μg. |
| Nasonex® Nasal Spray, 50 μg/actuation | ACTIVE_COMPARATOR | Days 1 through 7, each subject received a placebo run-in. Days 8 through 21, 2 sprays (2 × 50 μg) of Nasonex® Nasal Spray per nostril once daily for 14 days, Total Daily Dose = 4 × 50 μg = 200 μg. |
| Nasonex® Nasal Spray Suspnsn, 50 μg/actuation | ACTIVE_COMPARATOR | Days 1 through 7, each subject received a placebo run-in. Days 8 through 21, 2 sprays (2 × 50 μg) of Nasonex® Nasal Spray Suspension per nostril once daily for 14 days, Total Daily Dose = 4 × 50 μg = 200 μg. |
| Placebo Nasal Spray, 50 μL/actuation | PLACEBO_COMPARATOR | Days 1 through 7, each subject received a placebo run-in. Days 8 through 21, 2 sprays of placebo nasal spray per nostril once daily. |
| Name | Type | Description |
|---|---|---|
| Mometasone Furoate Monohydrate Nasal Spray, 50 μg/act. | DRUG | - |
| Nasonex® Nasal Spray, 50 μg/actuation | DRUG | - |
| Nasonex® Nasal Spray Suspnsn, 50 μg/actuation | DRUG | - |
| Placebo Nasal Spray, 50 μL/actuation | DRUG | - |
Inclusion Criteria: 1. Age: 12 years of age or older. 2. Signed informed consent form. For patients under the age of majority, the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form. 3. Sex: Male and/or non-pregnant, non-lactating fe...
Mometasone furoate, 50 μg/act is being developed for the treatment of the signs and symptoms of seasonal allergic rhinitis. It is a small molecule formulated as a nasal spray, delivering 50 micrograms of mometasone furoate per actuation. Seasonal allergic rhinitis is commonly known as hay fever.
Viatris Inc., which trades under the ticker VTRS, is the developer of mometasone furoate, 50 μg/act. Viatris is the company sponsoring the clinical development program for this nasal spray formulation for seasonal allergic rhinitis.
Mometasone furoate, 50 μg/act is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA for the treatment of seasonal allergic rhinitis. One Phase 1 trial has been completed, and no trials are currently active.
Mometasone furoate, 50 μg/act has been studied in one completed Phase 1 trial, NCT02109185. The trial compared mometasone nasal spray, Nasonex nasal spray, Nasonex nasal spray suspension, and placebo for seasonal allergies in 1,307 male and female volunteers aged 12 years and older. It was randomized, double blind, and placebo controlled.