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

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

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Perennial
• Intervention / Treatment: Drug: Mometasone furoate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 333
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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 Names: Nasonex
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	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (ESTIMATE): June 2, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P06332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php