Conditions: Rhinitis, Allergic, Perennial
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 80
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: MFNS 50 μg spray device. The dose will be as follows:

* 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.

Interventions: intervention 1: mometasone furoate
Intervention descriptions: intervention 1: 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.

Protocol document: