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

NCT ID: NCT01135134

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-10-31

Brief 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.

Conditions

Rhinitis, Allergic, Perennial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Mometasone furoate

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Nasonex

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 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

Other Identifiers

P06332

Identifier Type: -

Identifier Source: org_study_id