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Label indication ASMANEX ® TWISTHALER ® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age. FDA label
Mometasone Furoate · 1 trial · 1 indication
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over Days 1 to 14
The sum of patient-rated severity scores for four allergy symptoms : runny nose, nasal congestion, itchy nose, and sneezing based on a 4-point scale.
| Arm | Type | Description |
|---|---|---|
| Mometasone Furoate Nasal Spray, 50 mcg | EXPERIMENTAL | Mometasone Furoate Nasal Spray, 50 mcg. 4 actuations per day for 14 days. |
| Nasonex Nasal Spray, 50 mcg | ACTIVE_COMPARATOR | Nasonex (mometasone furoate monohydrate) Nasal Spray, 50 mcg. 4 actuations per day for 14 days. |
| Placebo Nasal Spray | PLACEBO_COMPARATOR | Placebo of Mometasone Furoate Nasal Spray. 4 actuations per day for 14 days. |
| Name | Type | Description |
|---|---|---|
| Mometasone Furoate Nasal Spray, 50 mcg | DRUG | a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate |
| Nasonex Nasal Spray, 50 mcg | DRUG | a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate |
| Placebo Nasal Spray | DRUG | a metered-dose, manual pump spray unit containing an aqueous suspension |
Inclusion Criteria: * If female and of child-bearing potential, have a negative urine pregnancy test and is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study * Documented positive allergic skin test, performed within the previous 12 months, to on...
Mometasone furoate is a small molecule nasal spray being developed for the treatment of seasonal allergic rhinitis. Amneal Pharmaceuticals is studying it in a Phase 3 program for relief of the signs and symptoms of seasonal allergic rhinitis in patients aged 12 years and older.
Amneal Pharmaceuticals, Inc. (ticker AMRX) is the developer of mometasone furoate nasal spray, 50 mcg. The company sponsored the Phase 3 therapeutic equivalence study of the product in seasonal allergic rhinitis conducted in the United States.
Mometasone furoate nasal spray, 50 mcg is in Phase 3 development. The program includes one completed Phase 3 trial, and no trials are currently listed as active. It is an investigational product and has not been approved by the FDA for this use.
Mometasone furoate nasal spray, 50 mcg was studied in NCT02125253, a completed Phase 3 trial titled Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis. The trial enrolled 811 participants in the United States.
NCT02125253 was a randomized, placebo-controlled Phase 3 study of mometasone furoate nasal spray, 50 mcg in seasonal allergic rhinitis. It enrolled 811 participants aged 12 years and older of all sexes in the United States, and the trial has been completed.