Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Mometasone furoate; Placebo
Intervention description: 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; 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
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 333.0
Sex: All
Minimum age: 5 Years
Maximum age: 15 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.