Clinical trial NCT01135134: Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No.P06332)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 333
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
timeFrame: Baseline and 2 weeks (or discontinuation)
Secondary outcomes:
measure: Change From Baseline in the Total Nasal Symptom Score at 1 Week
timeFrame: Baseline and 1 week
Other outcomes:
Locations:
Study officials:
References:
citation: 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.