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

NCT01165424 | Completed Phase 3 Results

• 1 other identifier: P06333
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events and Adverse Drug Reactions

  Baseline to Week 24

Secondary Outcomes (1)

• Change From Baseline in the Total Nasal Symptom Score

  Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)

Study Arms (1)

MFNS 50 μg device

EXPERIMENTAL

MFNS 50 μg spray device. The dose will be as follows: * 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.

Drug: mometasone furoate

Interventions

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.

Also known as: Nasonex

MFNS 50 μg device

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: July 19, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 24, 2024
• Results First Posted: January 23, 2012

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share