Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
MFNS 50 μg spray device * 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning. * 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
Number of Participants With Adverse Events and Adverse Drug Reactions
Time frame: Baseline to Week 24
Change From Baseline in the Total Nasal Symptom Score
Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.
Time frame: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)
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