Combining oxymetazoline and fluticasone to improve sleep apnea symptoms

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. A Double Blinded Placebo Controlled, Crossover Prospective Trial.

This study is testing if using a nasal spray that combines two medications can help people with mild sleep apnea and nasal congestion breathe better at night.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of South Florida (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT02630121 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a history of perennial allergic or non-allergic rhinitis and mild obstructive sleep apnea.

Not a fit: Patients with hypersensitivity to oxymetazoline or fluticasone propionate, or those receiving allergen immunotherapy without a stable regimen, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve sleep quality and overall health for patients suffering from mild obstructive sleep apnea and chronic nasal congestion.

How similar studies have performed: While this specific combination has not been extensively tested, similar approaches in managing nasal congestion and sleep apnea have shown promise in other studies.

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, 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 this trial is running

Tampa, Florida

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

Study contacts

• Study coordinator: Catherine R Smith

Conditions Sleep Apnea; Chronic Nasal Congestion