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

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No.P06332)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135134
• Other study ID #: P06332
• Status: Completed
• Phase: Phase 3
• Start date: June 2010
• Est. completion date: October 2010

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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 for whom any of the main exclusion criteria below is applicable will not be registered in this study.
• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in the Total Nasal Symptom Score at 1 Week	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 1 week