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

Inclusion criteria

• Male and female subjects 18 - 65 years of age.
• At least a one year history of perennial allergic or non-allergic rhinitis.
• Subjects must be on the maximum recommended doses of one of the following NGCS for at least one month. (See Table I)
• AHI per hour of sleep \> 5 and \<15, minimum SpO2 88, indicating mild obstructive sleep apnea).
• 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).
• Average Congestion Quantifier 7 score of 7 between visits 1 and 2 based on weekly symptoms (average of 2 scores).
• Willingness to participate as indicated by signed informed consent.

Exclusion criteria

• Presence of hypersensitivity to oxymetazoline or fluticasone propionate.
• Subjects receiving allergen immunotherapy but not on a stable maintenance regimen for at least 30 days before the first study visit.
• 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.
• Women who are pregnant or lactating.
• Other known nasal diseases likely to affect deposition of oxymetazoline such as sinusitis, nasal polyps, or major nasal structural malformations.
• Respiratory tract infections in the last 14 days.
• Infections requiring antibiotics in the last 14 days.
• Asthma or chronic obstructive pulmonary disease (COPD) requiring roflumilast or more than the recommended doses of inhaled corticosteroids, beta agonists, or antimuscarinic agents.
• No systemic glucocorticosteroids for one month prior or during the study.
• Cardiovascular disease with uncontrolled hypertension (BP160/80), arrhythmias and/or congestive heart failure.
• Insulin-dependent diabetes mellitus and/or diabetic retinopathy.
• Subjects with mild OSA (AHI 5-14) and SpO2 \<88 for \> 5 min during sleep that is identified during the screening portable sleep study.
• Hypertension requiring more than two drugs, with the exception of hydrochlorothiazide, to achieve control.
• A history of drug or alcohol abuse within the past 5 years.
• Subjects who are currently abusing alcohol, illicit drugs, benzodiazepines, or narcotics.
• Inability to cooperate, comply with study procedures or communicate with the investigator to successfully complete the study.
• A history of benign prostate hypertrophy necessitating treatment.
• A history of psychiatric problems which, in the opinion of the investigators, would impair participation in the study.
• Subjects with a planned hospitalization during the study.
• An infirmity, disability, or geographical location which seems likely to prevent regular attendance for subject visits.
• Subjects with obstructive sleep apnea syndrome requiring CPAP therapy.
• 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.
• Use of the following medications within the time period specified below prior to Day -7 (Table 2).