The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.
in Children Ages \>6 to \<12 with Perennial Allergic Rhinitis (PAR)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
489
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
Time frame: baseline to 28 Days
Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
Time frame: baseline to 28 days
Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo
change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms.
Time frame: baseline to 28 days
Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo
change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome.
Time frame: baseline to 28 Days
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