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
Trial Parameters
Brief Summary
The addition of intranasal oxymetazoline for two weeks to already instituted optimal doses of intranasal fluticasone propionate will decrease the total number of obstructive apneas and hypopneas per hour of sleep in subjects with perennial allergic or non-allergic rhinitis and mild obstructive sleep apnea who have persistent nasal congestion despite maximum doses of NGCS.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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, h