Oxymetazoline + Fluticasone for Obstructive Sleep Apnea

Overseen By Catherine R Smith

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of South Florida

Must be taking: Intranasal corticosteroids

Must not be taking: Systemic glucocorticosteroids, Roflumilast

Disqualifiers: Asthma, COPD, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a nasal spray called oxymetazoline to a fluticasone treatment can improve sleep for individuals with mild sleep apnea and ongoing nasal congestion. The trial focuses on reducing the frequency of breathing interruptions or shallow breathing during sleep. Participants will receive either oxymetazoline or a placebo (a dummy treatment with no active ingredients) alongside their fluticasone. This trial suits those who have experienced year-round nasal allergies or congestion for at least a year and have mild sleep apnea but remain congested despite using maximum doses of nasal sprays. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to determine how it can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not use certain medications within a specific time before the study starts. It's best to discuss your current medications with the study team to see if any adjustments are needed.

What is the safety track record for these treatments?

Research has shown that using Oxymetazoline and Fluticasone together is generally safe for treating conditions like allergies that cause a stuffy nose and issues with adenoids. One study found that this combination did not cause any serious side effects and proved very effective, with more than half of the patients experiencing significant improvements. While researchers are testing this treatment for sleep apnea, it has been well-tolerated in other conditions, suggesting it could be safe for this use as well. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of oxymetazoline and fluticasone for obstructive sleep apnea because it offers a fresh approach by combining a nasal decongestant with an anti-inflammatory agent. Oxymetazoline is a nasal spray that works as a decongestant to open up the airways, while fluticasone is a corticosteroid that reduces inflammation. This dual-action strategy is different from standard treatments like continuous positive airway pressure (CPAP) machines, which primarily focus on keeping airways open mechanically. By targeting both congestion and inflammation, this treatment has the potential to improve breathing during sleep in a way that current mechanical or surgical options do not.

What evidence suggests that this trial's treatments could be effective for obstructive sleep apnea?

This trial will compare the combination of oxymetazoline hydrochloride and fluticasone propionate with a placebo and fluticasone propionate for treating obstructive sleep apnea. Studies have shown that using oxymetazoline hydrochloride and fluticasone propionate together can greatly reduce symptoms of obstructive sleep apnea. Specifically, many patients experienced a 50% drop in their apnea-hypopnea index (AHI), which measures how often breathing stops or slows during sleep. Research also shows that this treatment helps people adhere to positive airway pressure (PAP) therapy, a common treatment for sleep apnea. Additionally, this combination significantly reduces nighttime nasal congestion, leading to better sleep quality. Both ingredients are already approved for other uses, making them a promising option for those dealing with sleep apnea and nasal congestion. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Willingness to participate as indicated by signed informed consent

Exclusion Criteria

I've been on allergen immunotherapy but not on a stable dose for 30 days.

I have not had a respiratory infection in the last 2 weeks.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oxymetazoline hydrochloride plus fluticasone propionate or placebo plus fluticasone propionate for 2 weeks in a crossover design

2 weeks

Visits at the start and end of each treatment arm

Follow-up

Participants are monitored for changes in nasal congestion and quality of life using various questionnaires

7 weeks

Weekly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Oxymetazoline Hydrochloride
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Oxymetazoline Hydrochloride /Fluticasone Propionate Active Control 1 Intervention

Oxymetazoline Hydrochloride 2 Sprays QHS Fluticasone Propionate 1 spray BID

Group II: Placebo/Fluticasone Propionate Placebo Group 1 Intervention

Placebo Spray 2 Sprays QHS Fluticasone Propionate 1 spray BID

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Published Research Related to This Trial

In a study of 195 children with obstructive sleep apnea syndrome (OSAS), the combination of montelukast sodium and mometasone furoate significantly improved clinical symptoms and reduced the apnea-hypopnea index after 12 weeks compared to baseline.

The combined treatment (group C) was more effective than either montelukast or mometasone alone, leading to quicker relief of symptoms, although it was less effective in patients with severe tonsil hypertrophy (≥ grade 3).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effect of montelukast sodium combined with inhaled corticosteroids in the treatment of OSAS children. Yang, DZ., Liang, J., Zhang, F., et al.[2021]

In a double-blind, placebo-controlled study of 32 subjects with perennial allergic rhinitis, topical nasal fluticasone significantly improved subjective sleep quality compared to placebo, indicating its potential efficacy in managing sleep disturbances related to nasal congestion.

While fluticasone reduced daytime sleepiness and fatigue by over 10%, this change was not statistically significant, and there was no observed impact on the apnea/hypopnea index, suggesting that while fluticasone helps with sleep perception, it may not affect sleep apnea severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of topical nasal fluticasone on objective sleep testing and the symptoms of rhinitis, sleep, and daytime somnolence in perennial allergic rhinitis. Craig, TJ., Mende, C., Hughes, K., et al.[2016]

The fixed dose combination (FDC) of Fluticasone Furoate and Oxymetazoline Hydrochloride significantly reduced night-time Total Nasal Symptom Score compared to Fluticasone alone, showing effectiveness from day 3 through day 28 in a study of 250 patients with moderate-to-severe allergic rhinitis.

Both treatments were well tolerated, with no significant difference in the occurrence of rebound congestion or rhinitis medicamentosa after stopping the medication, indicating that the FDC is a safe option for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion. Kumar, RS., Jain, MK., Kushwaha, JS., et al.[2022]

Obstructive sleep apnoea is a serious health issue, primarily treated with nasal continuous positive airway pressure (CPAP), while various pharmacological agents are explored as adjunctive treatments, including intranasal corticosteroids and decongestants.

The review highlights that while many pharmacological options exist for treating sleep apnoea and its symptoms, some have limited research backing, indicating a need for further studies to establish their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological management of sleep apnoea. Abad, VC., Guilleminault, C.[2019]

Intranasal corticosteroid therapy significantly reduces the apnea-hypopnea index in patients with obstructive sleep apnea (OSA) compared to placebo, based on a meta-analysis of five randomized controlled trials involving 221 participants.

Despite the positive findings, the evidence is limited by potential biases and variability among the studies, indicating a need for further research to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal corticosteroid therapy in the treatment of obstructive sleep apnea: A meta-analysis of randomized controlled trials. Liu, HT., Lin, YC., Kuan, YC., et al.[2017]

In a study involving 12 patients with obstructive sleep apnea (OSA) and chronic nasal congestion, the nasal decongestant xylometazoline significantly improved nasal airflow but did not lead to a meaningful reduction in the overall apnea/hypopnea index, indicating limited efficacy in treating OSA.

While xylometazoline showed a slight reduction in the apnea/hypopnea index shortly after application, the overall results suggest that nasal congestion may have a minor role in OSA, as the treatment did not significantly improve sleep quality or reduce daytime sleepiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does nasal decongestion improve obstructive sleep apnea? Clarenbach, CF., Kohler, M., Senn, O., et al.[2012]

In a 16-week study involving 18 young adults with mild asthma, high-dose inhaled fluticasone propionate improved upper airway collapsibility during sleep, indicating potential benefits for obstructive sleep apnea.

The treatment increased tongue strength but decreased endurance, suggesting that while some aspects of airway function improved, others may have been negatively affected, highlighting the complexity of the drug's effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of inhaled fluticasone on upper airway during sleep and wakefulness in asthma: a pilot study. Teodorescu, M., Xie, A., Sorkness, CA., et al.[2021]

In a clinical trial involving 240 children with adenoid hypertrophy and allergic rhinitis, the combination of mometasone furoate (MF) and oxymetazoline (OXY) was found to be more effective than either treatment alone, particularly in reducing nasal congestion and improving nasal volume.

The study demonstrated that 39% of children responded positively to MF alone, and for those who did not respond, the MF/OXY combination significantly improved symptoms, indicating a safe and effective treatment option with a rapid onset of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of mometasone furoate and oxymetazoline for the treatment of adenoid hypertrophy concomitant with allergic rhinitis: A randomized controlled trial. Liu, W., Zhou, L., Zeng, Q., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02630121?term=oxymetazoline&rank=10

NCT02630121 | Effect of Oxymetazoline Hydrochloride in ... The proportion of subjects demonstrating a 50% reduction in the apnea hypopnea index after treatment with oxymetazoline hydrochloride and fluticasone propionate ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39492574/

Improvement of CPAP tolerance and adherence in a ... The combination of once- daily intranasal oxymetazoline with fluticasone led to significant improvement in tolerance and adherence to PAP therapy.

3. withpower.com withpower.com/trial/phase-4-sleep-apnea-obstructive-2022-40457

Oxymetazoline + Fluticasone for Obstructive Sleep Apnea The fixed dose combination (FDC) of Fluticasone Furoate and Oxymetazoline Hydrochloride significantly reduced night-time Total Nasal Symptom Score compared to ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/490216

Effect of Oxymetazoline Hydrochloride in Combination With ... Proportion of the subjects with 50% reduction in AHI. Active Comparator: Oxymetazoline Hydrochloride /Fluticasone Propionate. Oxymetazoline ...

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT02630121/

Trial | NCT02630121 Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9196668/

Efficacy and Safety of Fluticasone Furoate and Oxymetazoline ... The study demonstrated statistical superiority of the fixed dose combination of Fluticasone Furoate and Oxymetazoline Hydrochloride Nasal Spray ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38195833/

A Real-World Observational Study to Evaluate the Safety ... With respect to effectiveness, the investigators reported very good effectiveness in 52.12% of patients. No serious adverse events were reported ...