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

Organon

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Placebo; Drug: Mometasone furoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135134

P06332

Details and patient eligibility

About

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.

Enrollment: 333 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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333 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: Mometasone furoate

MF placebo nasal spray

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo