Conditions: Rhinitis, Allergic, Perennial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 333
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.

Detailed description:

Arms:
arm 1: The dose will be as follows:

* 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks arm 2: Administration will be as follows:

* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks

Interventions: intervention 1: Mometasone furoate intervention 2: Placebo
Intervention descriptions: intervention 1: The study drug is MFNS (50 μg spray device) and the dose will be:

* 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks intervention 2: MF Placebo nasal spray and administration will be as follows:

* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks

Protocol document: