Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED)
This study has been terminated.
(Very poor enrollment)
First Posted: June 26, 2007
Last Update Posted: July 29, 2009
Information provided by:
This study will hope to show that the treatment of the patient's perennial allergic rhinitis (PAR) using Nasonex® (mometasone furoate nasal spray) will result in improvement of the nasal symptoms of PAR and of nighttime sleep-disordered breathing, thereby resulting in improved sleep quality, less daytime sleepiness, improved daytime functioning, and improved quality of life.
|Perennial Allergic Rhinitis||Drug: Mometasone Furoate Nasal Spray Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Single-Site Study Of Mometasone Furoate Nasal Spray (MFNS) In Subjects With Mild-Moderate Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) Associated With Perennial Allergic Rhinitis (PAR) Using Polysomnographic Recordings of Sleep Parameters|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- The Change From Baseline in the Number of Apnea-Hypopnea Episodes Per Hour (Apnea-Hypopnea Index (AHI)
|Study Start Date:||September 2006|
|Study Completion Date:||October 2007|
Drug: Mometasone Furoate Nasal Spray
Nasonex Nasal Spray 50 mcg/spray, 200 mcg (4 sprays) once daily every morning for 28 days.
Other Name: SCH 32088
|Placebo Comparator: Placebo||
Placebo Nasal Spray 4 sprays once daily every morning for 28 days.
Contacts and Locations
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