Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea

Eligibility Criteria

• 1. Male and female subjects 18 - 65 years of age.
• 2. At least a one year history of perennial allergic or non-allergic rhinitis.
• 3. Subjects must be on the maximum recommended doses of one of the following NGCS for at least one month. (See Table I)
• 4. AHI per hour of sleep \> 5 and \<15, minimum SpO2 88, indicating mild obstructive sleep apnea).
• 5. Average Nasal Congestion VAS of \> 3-10 indicating moderate to severe nasal congestion between visits 1 and 2 based on daily symptoms (average of 7 scores).
• 6. Average Congestion Quantifier 7 score of 7 between visits 1 and 2 based on weekly symptoms (average of 2 scores).
• 7. Willingness to participate as indicated by signed informed consent.
• 1. Presence of hypersensitivity to oxymetazoline or fluticasone propionate.
• 2. Subjects receiving allergen immunotherapy but not on a stable maintenance regimen for at least 30 days before the first study visit.
• 3. If the subject has perennial allergic rhinitis, he/she should not be entered into this study eight weeks before, during, or six weeks after any seasonal exacerbation.
• 4. Women who are pregnant or lactating.
• 5. Other known nasal diseases likely to affect deposition of oxymetazoline such as sinusitis, nasal polyps, or major nasal structural malformations.
• 6. Respiratory tract infections in the last 14 days.
• 7. Infections requiring antibiotics in the last 14 days.
• 8. Asthma or chronic obstructive pulmonary disease (COPD) requiring roflumilast or more than the recommended doses of inhaled corticosteroids, beta agonists, or antimuscarinic agents.
• 9. No systemic glucocorticosteroids for one month prior or during the study.
• 10. Cardiovascular disease with uncontrolled hypertension (BP160/80), arrhythmias and/or congestive heart failure.
• 11. Insulin-dependent diabetes mellitus and/or diabetic retinopathy.
• 12. Subjects with mild OSA (AHI 5-14) and SpO2 \<88 for \> 5 min during sleep that is identified during the screening portable sleep study.
• 13. Hypertension requiring more than two drugs, with the exception of hydrochlorothiazide, to achieve control.
• 14. A history of drug or alcohol abuse within the past 5 years.
• 15. Subjects who are currently abusing alcohol, illicit drugs, benzodiazepines, or narcotics.
• 16. Inability to cooperate, comply with study procedures or communicate with the investigator to successfully complete the study.
• 17. A history of benign prostate hypertrophy necessitating treatment.
• 18. A history of psychiatric problems which, in the opinion of the investigators, would impair participation in the study.
• 19. Subjects with a planned hospitalization during the study.
• 20. An infirmity, disability, or geographical location which seems likely to prevent regular attendance for subject visits.
• 21. Subjects with obstructive sleep apnea syndrome requiring CPAP therapy.
• 22. Subjects diagnosed with central sleep apnea (\> 5 central events per hour) or moderate to severe OSA (AHI \> 15) and SpO2 \<88 for \> 5 min during sleep identified during screening.
• 23. Use of the following medications within the time period specified below prior to Day -7 (Table 2).