RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2023-04-01

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02630121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Study Contact

Catherine R Smith

CONTACT

813-631-4024

catherinesmith@health.usf.edu

Study Locations (Sites)

Usf Asthma Allergy and Immunology Cru

Tampa, Florida, 33613

United States

Collaborators and Investigators

Sponsor: University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2026-04

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Sleep Apnea
Chronic Nasal Congestion