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.

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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mometasone furoate

Drug

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

Drug

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

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jun 2, 2010
Registry last updated: May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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