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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2010

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
    • Time Frame: Baseline and 2 weeks (or discontinuation)
    • 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.

Secondary Measures

  • Change From Baseline in the Total Nasal Symptom Score at 1 Week
    • Time Frame: Baseline and 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

Okamoto Y, Suzuki I . Multicenter, double-blind, randomized, placebo-controlled study of mometasone furoate nasal spray in Japanese pediatric subjects with perennial allergic rhinitis . Oto-rhino Laryngol Tokyo. 2013;106(11):1045-1057.

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