Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,111
GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
GSP 301 placebo NS administered as 2 sprays/nostril
Glenmark Investigational Site 10
Austin, Texas, United States
Glenmark Investigational Site 5
Austin, Texas, United States
Glenmark Investigational Site 6
Austin, Texas, United States
Change in rTNSS From Baseline to End of Treatment
Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching. The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome. The severity scale for each symptom evaluation was defined as follows: * 0 = absent (no sign/symptom evident) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate \[i.e., causes interference with activities of daily living and/or sleeping\])
Time frame: 14 days
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Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril
Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
Glenmark Investigational Site 2
Kerrville, Texas, United States
Glenmark Investigational Site 7
New Braunfels, Texas, United States
Glenmark Investigational Site 3
San Antonio, Texas, United States
Glenmark Investigational Site 4
San Antonio, Texas, United States
Glenmark Investigational Site 8
San Antonio, Texas, United States
Glenmark Investigational Site 9
San Antonio, Texas, United States
Glenmark Investigational Site 1
Waco, Texas, United States