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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00359216 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Perennial Allergic Rhinitis Obstructive Sleep Apnea Sleep Disorder |
Drug: Mometasone furoate nasal spray Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 Sleep-disordered Breathing Associated With Perennial Allergic Rhinitis (PAR) Using Home-Monitored Cardio-Respiratory Methodology. |
| Enrollment: | 30 |
| Study Start Date: | May 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Drug: Placebo
Placebo nasal spray. Each subject to take 4 sprays once daily in the morning.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00359216 History of Changes |
| Other Study ID Numbers: | P04726 |
| Study First Received: | July 31, 2006 |
| Results First Received: | January 23, 2009 |
| Last Updated: | May 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Hypopnea Syndrome |
|
Rhinitis Rhinitis, Allergic, Perennial Sleep Apnea Syndromes Sleep Disorders Parasomnias Sleep Apnea, Obstructive Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Apnea Respiration Disorders Sleep Disorders, Intrinsic Dyssomnias Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |