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

NCT01135134 | Completed Phase 3 Results

• 1 other identifier: P06332
• Study Type: interventional
• Target: 333
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in the Total Nasal Symptom Score at 1 Week

  Baseline and 1 week

Study Arms (2)

Mometasone furoate nasal spray (MFNS) (50 μg spray device)

EXPERIMENTAL

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

MF placebo nasal spray

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Nasonex

Mometasone furoate nasal spray (MFNS) (50 μg spray device)

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

MF placebo nasal spray

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 28, 2024
• Results First Posted: November 3, 2011

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share