Combining oxymetazoline and fluticasone to improve sleep apnea symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of adding intranasal oxymetazoline to optimal doses of intranasal fluticasone propionate in reducing the apnea/hypopnea index (AHI) in individuals with persistent nasal congestion and mild obstructive sleep apnea. Participants will be monitored using the NOX T3 portable sleep monitor to assess changes in their sleep patterns. Additionally, various questionnaires will be utilized to measure nasal congestion and its impact on quality of life. The goal is to determine if this combination therapy can provide better symptom relief for patients who have not responded adequately to existing treatments.

Why it matters

Who can join: the full rules

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, 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).

Where it's running

• Usf Asthma Allergy and Immunology Cru
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Catherine R Smith
• Email: catherinesmith@health.usf.edu
• Phone: 813-631-4024

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.