Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,180
FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
2 sprays in each nostril twice daily for 14 days
2 sprays in each nostril twice daily for 14 days
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).
Time frame: 14 days
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2 sprays in each nostril twice daily for 14 days
Investigational Site 20
Mission Viejo, California, United States
Investigational Site 31
San Diego, California, United States
Investigational Site 29
San Jose, California, United States
Investigational Site 25
Centennial, Colorado, United States
Investigational Site 22
Colorado Springs, Colorado, United States
Investigational Site 10
Jupiter, Florida, United States
Investigational Site 30
Miami, Florida, United States
Investigational Site 37
Marietta, Georgia, United States
Investigational Site 15
Stockbridge, Georgia, United States
Investigational Site 23
Stockbridge, Georgia, United States
...and 27 more locations