To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
811
a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate
a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate
a metered-dose, manual pump spray unit containing an aqueous suspension
Isis Clinical Research
Austin, Texas, United States
Austin Clinical Research
Austin, Texas, United States
Sirius Clinical Research
Austin, Texas, United States
Change from Baseline rTNSS
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over Days 1 to 14
Time frame: Days 1 - 14
Total Nasal Symptom Score (TNSS)
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.
Time frame: Days 1 - 14
Change in Baseline iTNSS
Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over Days 1 to 14.
Time frame: Days 1 - 14
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