To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
601
FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks
2 spray in each nostril twice daily for 52 weeks
2 spray in each nostril twice daily for 52 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs).
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
Time frame: 52 weeks
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Investigational Site 2
Hot Springs, Arkansas, United States
Investigational Site 28
Encinitas, California, United States
Investigational Site 27
San Diego, California, United States
Investigational Site 29
San Diego, California, United States
Investigational Site 32
Denver, Colorado, United States
Investigational Site 26
Aventura, Florida, United States
Investigational Site 9
Miami, Florida, United States
Investigational Site 33
Tallahassee, Florida, United States
Investigational Site 11
Stockbridge, Georgia, United States
Investigational Site 4
Louisville, Kentucky, United States
...and 24 more locations