The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to \<12 years old who have seasonal allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
348
Primary Efficacy
change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.
Time frame: 15 days of treatment
Safety
* Subject-reported adverse experiences (incidence, type, and severity of adverse events) * Nasal Examinations * Vital signs assessments
Time frame: entire length of study (day 1 to day 22)
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Clinical Research Center of Alabama,LLC
Birmingham, Alabama, United States
Little Rock Allergy and Asthma Clinical research Center
Little Rock, Alaska, United States
Clinical Research Atlanta
Atlanta, Georgia, United States
Aeroallergy Research Laboratories of Savannah
Savannah, Georgia, United States
Atlanta Allergy and Asthma Clinic
Stockbridge, Georgia, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, United States
Clinical Research Institute of Indiana
Indianapolis, Indiana, United States
Family Allergy and Asthma Reserach
Louisville, Kentucky, United States
Institute for Asthma and Allergy PC
Wheaton, Maryland, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, United States
...and 21 more locations