The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)
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|ClinicalTrials.gov Identifier: NCT00359216|
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : August 3, 2009
Last Update Posted : April 12, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Perennial Allergic Rhinitis Obstructive Sleep Apnea Sleep Disorder||Drug: Mometasone furoate nasal spray Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
|Experimental: Mometasone furoate nasal spray||
Drug: Mometasone furoate nasal spray
MFNS, 50 mcg/spray. Each subject to take 200 mcg (4 sprays) once daily in the morning.
Other Name: Nasonex
|Placebo Comparator: Placebo nasal spray||
Placebo nasal spray. Each subject to take 4 sprays once daily in the morning.
Primary Outcome Measures :
- Apnea-Hypopnea Index [ Time Frame: change from baseline (screening) at the end of 28 days of treatment ]Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.
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