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

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.

• Drug: Mometasone furoate

  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
  Other Name: Nasonex
• Drug: Placebo

  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

• Experimental: Mometasone furoate nasal spray (MFNS) (50 μg spray device)

  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
  Intervention: Drug: Mometasone furoate
• Placebo Comparator: MF placebo nasal spray

  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
  Intervention: Drug: Placebo

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.