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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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
|---|---|
| Mometasone furoate nasal spray: Experimental |
Drug: Mometasone furoate nasal spray
MFNS, 50 mcg/spray. Each subject to take 200 mcg (4 sprays) once daily in the morning.
|
| Placebo nasal spray: Placebo Comparator |
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: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P04726 |
| Study First Received: | July 31, 2006 |
| Results First Received: | January 23, 2009 |
| Last Updated: | June 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00359216 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hypopnea Syndrome |
|
Anti-Inflammatory Agents Sleep Apnea, Obstructive Sleep Disorders Rhinitis Sleep Disorders, Intrinsic Signs and Symptoms Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Rhinitis, Allergic, Perennial Mental Disorders Therapeutic Uses Sleep Apnea Syndromes |
Otorhinolaryngologic Diseases Immune System Diseases Apnea Mometasone furoate Respiration Disorders Nervous System Diseases Dyssomnias Anti-Allergic Agents Nose Diseases Pharmacologic Actions Hypersensitivity, Immediate Neurologic Manifestations Respiratory Hypersensitivity |