NCT02630121 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
| NCT ID | NCT02630121 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of South Florida |
| Condition | Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 52 participants in total. It began in 2023-04-01 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02630121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02630121 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02630121 currently recruiting?
Yes, NCT02630121 is actively recruiting participants. Contact the research team at catherinesmith@health.usf.edu for enrollment information.
Where is the NCT02630121 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT02630121 clinical trial?
NCT02630121 is sponsored by University of South Florida. The trial plans to enroll 52 participants.