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Oxymetazoline + Fluticasone for Obstructive Sleep Apnea
Phase 4
Recruiting
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female subjects 18 - 65 years of age
At least a one year history of perennial allergic or non-allergic rhinitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights
Study Summary
This trial suggests that adding intranasal oxymetazoline to already-prescribed intranasal fluticasone propionate can decrease the number of apneas and hypopneas per hour of sleep in people with mild obstructive sleep apnea.
Who is the study for?
Adults aged 18-65 with mild obstructive sleep apnea and a history of perennial allergic or non-allergic rhinitis experiencing moderate to severe nasal congestion despite maximum doses of nasal corticosteroids. Participants must not have severe allergies, respiratory infections, uncontrolled hypertension, COPD, asthma requiring strong medication, or be pregnant.Check my eligibility
What is being tested?
The trial is testing if adding Oxymetazoline Hydrochloride to Fluticasone Propionate can reduce the number of apneas and hypopneas during sleep in patients with persistent nasal congestion and mild sleep apnea compared to a placebo.See study design
What are the potential side effects?
Oxymetazoline may cause temporary discomfort such as burning or stinging in the nose, sneezing, dryness inside the nose; rarely it can lead to rebound congestion if used too frequently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I have had year-round allergies or nasal symptoms for at least a year.
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I have been on the highest dose of a specific cholesterol medication for at least a month.
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I have moderate to severe nasal congestion.
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I have been on the highest dose of a specific medication for over a month.
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I have moderate to severe nasal congestion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of subjects demonstrating a 50% reduction in the apnea hypopnea index after treatment with oxymetazoline hydrochloride and fluticasone propionate for 2 weeks.
Secondary outcome measures
The proportion of subjects demonstrating an improvement in moderate to severe upper airway flow limitation as measured by a change in the flattening index after treatment with oxymetazoline hydrochloride and fluticasone propionate for 2 weeks.
Other outcome measures
The Congestion Quantifier 7 (CQ7) questionnaire will be used to assess for an improvement in nasal congestion based on symptoms.
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) will be used to assess the impact of perennial rhinitis and nasal congestion on activities of daily living.
The proportion of subjects with a decrease in the severity of daily nasal congestion as measured by the Nasal Congestion VAS.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Oxymetazoline Hydrochloride /Fluticasone PropionateActive Control1 Intervention
Oxymetazoline Hydrochloride 2 Sprays QHS Fluticasone Propionate 1 spray BID
Group II: Placebo/Fluticasone PropionatePlacebo Group1 Intervention
Placebo Spray 2 Sprays QHS Fluticasone Propionate 1 spray BID
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Sleep Apnea include Continuous Positive Airway Pressure (CPAP), oral appliances, and medications like intranasal oxymetazoline. CPAP works by maintaining an open airway through continuous air pressure, preventing airway collapse during sleep.
Oral appliances reposition the jaw to keep the airway open. Intranasal oxymetazoline reduces nasal congestion by causing vasoconstriction, which decreases nasal resistance and improves airflow.
These treatments are crucial as they alleviate airway obstruction, reduce apneas and hypopneas, and improve sleep quality, thereby mitigating associated risks such as cardiovascular complications and daytime sleepiness.
New frontiers in pharmacologic obstructive sleep apnea treatment: A narrative review.Effects of hypnotics on obstructive sleep apnea endotypes and severity: Novel insights into pathophysiology and treatment.Usefulness of rhinomanometry in the identification and treatment of patients with obstructive sleep apnoea: an algorithm for predicting the relationship between nasal resistance and continuous positive airway pressure. a retrospective study.
New frontiers in pharmacologic obstructive sleep apnea treatment: A narrative review.Effects of hypnotics on obstructive sleep apnea endotypes and severity: Novel insights into pathophysiology and treatment.Usefulness of rhinomanometry in the identification and treatment of patients with obstructive sleep apnoea: an algorithm for predicting the relationship between nasal resistance and continuous positive airway pressure. a retrospective study.
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Who is running the clinical trial?
University of South FloridaLead Sponsor
414 Previous Clinical Trials
188,245 Total Patients Enrolled
1 Trials studying Sleep Apnea
4 Patients Enrolled for Sleep Apnea
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I have had year-round allergies or nasal symptoms for at least a year.I have been on the highest dose of a specific cholesterol medication for at least a month.I've been on allergen immunotherapy but not on a stable dose for 30 days.If you have year-round allergies, you should not participate in this study for eight weeks before, during, or six weeks after a seasonal allergy flare-up.I have not had a respiratory infection in the last 2 weeks.I haven't taken antibiotics for infections in the last 14 days.You have had issues with drugs or alcohol in the past 5 years.You are currently using alcohol, illegal drugs, benzodiazepines, or narcotics excessively.I have been treated for an enlarged prostate.I am scheduled to be hospitalized during the study.I have sleep apnea and use a CPAP machine.I haven't taken any of the specified medications within 7 days before the trial.I am not pregnant or breastfeeding.I haven't taken steroids for a month.I have moderate to severe nasal congestion.I need strong medication for my asthma or COPD.I have heart problems with high blood pressure or irregular heartbeat.I have been on the highest dose of a specific medication for over a month.I have mild sleep apnea with low oxygen levels during sleep.I am between 18 and 65 years old.I can follow the study's procedures and communicate with the research team.Your congestion score is consistently 7 or higher based on your weekly symptoms.I have diabetes that requires insulin and/or I have eye problems due to diabetes.You have had ongoing allergies or runny nose for at least a year, whether it's from allergies or not.I need more than two medications (excluding hydrochlorothiazide) to control my high blood pressure.I have been diagnosed with severe sleep apnea or my oxygen levels drop below 88% for more than 5 minutes while I sleep.I have moderate to severe nasal congestion.You are allergic to oxymetazoline or fluticasone propionate.I have conditions like sinusitis, nasal polyps, or major nasal issues that could affect medication absorption.You have mild obstructive sleep apnea, with an average of 5 to 15 breathing interruptions per hour during sleep and a minimum oxygen level of 88%.Your average congestion score from two visits is 7 based on your weekly symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo/Fluticasone Propionate
- Group 2: Oxymetazoline Hydrochloride /Fluticasone Propionate
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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