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

Rhinitis, Allergic, Perennial Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165424
• Other study ID #: P06333
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• mometasone furoate
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events and Adverse Drug Reactions		Baseline to Week 24
Secondary	Change From Baseline in the Total Nasal Symptom Score	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.	Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)