What side effects are associated with this type of intervention?

Common treatments for sleep apnea include Continuous Positive Airway Pressure (CPAP) and pharmacotherapy. Intranasal oxymetazoline, used to reduce nasal congestion, can cause side effects such as nasal dryness, irritation, and rebound congestion with prolonged use. CPAP therapy may lead to discomfort, nasal congestion, dryness, and skin irritation from the mask. Pharmacotherapy options like acetazolamide can cause side effects including dizziness, fatigue, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved various treatments for sleep apnea, primarily focusing on continuous positive airway pressure (CPAP) devices, oral appliances, and surgical interventions. While there are no specific FDA approvals for intranasal oxymetazoline as a primary treatment for sleep apnea, it is commonly used off-label to reduce nasal congestion, which can help improve airflow during sleep. Other related drugs include intranasal corticosteroids like fluticasone propionate, which are used to manage nasal congestion in patients with sleep apnea.

What other types of research exist?

A promising alternative to intranasal oxymetazoline for sleep apnea patients is the combination of intranasal fluticasone propionate with other treatments that address underlying conditions such as allergic rhinitis. Additionally, exploring new classes of vasodilator drugs like the 4-trifluoromethylimidazole derivatives, which have shown efficacy in lowering arterial pressure and improving blood flow, may offer novel therapeutic options. For pulmonary hypertension-related sleep apnea, BAY 41-2272 and other guanylate cyclase stimulators like riociguat could be considered due to their efficacy in managing pulmonary conditions.

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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

Must not have

Infections requiring antibiotics in the last 14 days

A history of benign prostate hypertrophy necessitating treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial tests if adding oxymetazoline nasal spray to fluticasone propionate nasal spray can help people with year-round nasal allergies or non-allergic rhinitis and mild sleep apnea who still have nasal congestion despite using other treatments. The sprays aim to reduce swelling and inflammation in the nose, improving breathing during sleep. Fluticasone propionate is a well-established treatment for nasal symptoms and inflammation in allergic rhinitis.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken antibiotics for infections in the last 14 days.

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I have been treated for an enlarged prostate.

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I am scheduled to be hospitalized during the study.

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I have sleep apnea and use a CPAP machine.

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I am not pregnant or breastfeeding.

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I need strong medication for my asthma or COPD.

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I haven't taken steroids for a month.

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I have heart problems with high blood pressure or irregular heartbeat.

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I have mild sleep apnea with low oxygen levels during sleep.

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I can follow the study's procedures and communicate with the research team.

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I have diabetes that requires insulin and/or I have eye problems due to diabetes.

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I have been diagnosed with severe sleep apnea or my oxygen levels drop below 88% for more than 5 minutes while I sleep.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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.

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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

0 / 18Eligibility criteria met

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.