The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)
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.
Timeline
- Start
- 2006-05
- Primary completion
- 2008-01
- Completion
- 2008-01
Outcome
Missed primary endpoint
registry analysis (unspecified test); Mometasone Furoate Nasal Spray vs Placebo Nasal Spray; p = 0.9219; ANCOVA NCT00359216 ↗
paper The apnea-hypopnea index at study end was not statistically significantly different between groups. PMID 20642206 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mometasone furoate | Other / unclassified | 200 ug | Intranasal |