NCT00359216

The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)

A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Single-Site Study of Mometasone Furoate Nasal Spray (MFNS) In Subjects With Sleep-disordered Breathing Associated With Perennial Allergic Rhinitis (PAR) Using Home-Monitored Cardio-Respiratory Methodology.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak Nasal Inspiratory Flow (PNIF), Embletta device home-monitored cardiopulmonary evaluations, and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age with symptomatic PAR (with or without SAR) will be selected and randomized at one study site. The anticipated duration of subject participation in the study is approximately 39 days. Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening period. Following the run-in period, subjects who meet the qualifications at the Baseline Visit will be treated with study medication for 4 weeks.

Conditions

• Perennial Allergic Rhinitis
• Obstructive Sleep Apnea
• Sleep Disorder

Interventions

Type	Name	Description
DRUG	Mometasone furoate nasal spray	MFNS, 50 mcg/spray. Each subject to take 200 mcg (4 sprays) once daily in the morning.
DRUG	Placebo	Placebo nasal spray. Each subject to take 4 sprays once daily in the morning.

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-08-01
• Last updated: 2024-05-23
• Results posted: 2009-08-03