A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)

Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.

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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

3 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

Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
Male or female outpatients aged 3 to 15 years at the time of providing informed consent.

Exclusion criteria

Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require 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 with coexisting fungal infection in nasal/sinus cavity
Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period

Treatment and study plan

Mometasone furoate

Drug

MFNS 50 μg spray device

3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.

Other names: Nasonex

Primary outcomes

Number of Participants With Adverse Events and Adverse Drug Reactions

Time frame: Baseline to Week 24

Secondary outcomes

Change From Baseline in the Total Nasal Symptom Score

Time frame: Baseline and Weeks 2, 4, 8, 12, and 24 (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, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Study of Long-term (12-24 Weeks) Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No. P06333)

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jul 19, 2010
Registry last updated: May 24, 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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