Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No.P06332)

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: Mometasone furoate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria: Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period. Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen). Male or female outpatients aged 5 to 15 years at the time of providing informed consent. Exclusion Criteria: Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study. Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics Subjects with repeated epistaxis Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis. Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone furoate nasal spray (MFNS) (50 μg spray device)<br>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 | Drug: Mometasone furoate<br>* 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<br>* Other names: Nasonex;|
| Placebo Comparator: MF placebo nasal spray<br>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 | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Total Nasal Symptom Score at 2 Weeks | 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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. | Baseline and 2 weeks (or discontinuation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Total Nasal Symptom Score at 1 Week | 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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. | Baseline and 1 week |