Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,176
2 spray in each nostril twice daily for 14 days
2 spray in each nostril twice daily for 14 days
2 spray in each nostril twice daily for 14 days
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged 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: Baseline and day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
2 spray in each nostril twice daily for 14 days
Investigational Site 406
Mission Viejo, California, United States
Investigational Site 414
Orange, California, United States
Investigational Site 435
San Diego, California, United States
Investigational Site 420
Centennial, Colorado, United States
Investigational Site 444
Colorado Springs, Colorado, United States
Investigational Site 428
Aventura, Florida, United States
Investigational Site 412
Miami, Florida, United States
Investigational Site 436
Bethesda, Maryland, United States
Investigational Site 432
South Dartmouth, Massachusetts, United States
Investigational Site 426
Minneapolis, Minnesota, United States
...and 33 more locations