Oxymetazoline + Fluticasone for Obstructive Sleep Apnea

Overseen By Catherine R Smith

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug Oxymetazoline + Fluticasone for Obstructive Sleep Apnea?

Research shows that nasal decongestants like xylometazoline can improve nasal airflow, which might help with sleep apnea symptoms. Additionally, fluticasone, a nasal steroid, has been shown to improve subjective sleep quality in people with nasal congestion, although it doesn't change the apnea/hypopnea index (a measure of sleep apnea severity). ^{1 2 3 4 5}

Is the combination of Oxymetazoline and Fluticasone safe for use in humans?

Research indicates that the combination of Oxymetazoline and Fluticasone is generally safe for treating conditions like allergic rhinitis and adenoid hypertrophy, with studies showing effective symptom reduction and no significant safety concerns. ^{1 3 5 6 7}

How does the drug oxymetazoline + fluticasone differ from other treatments for obstructive sleep apnea?

The combination of oxymetazoline and fluticasone is unique because it targets nasal congestion, which can contribute to obstructive sleep apnea, by using a nasal spray that combines a decongestant (oxymetazoline) and a corticosteroid (fluticasone). This approach is different from other treatments that may not focus on nasal congestion as a factor in sleep apnea. ^{1 3 5 7 8}

Eligibility Criteria

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 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.

Exclusion Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Oxymetazoline Hydrochloride (Decongestant)
• Placebo (Other)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Does nasal decongestion improve obstructive sleep apnea? [2012]

2. England pubmed.ncbi.nlm.nih.gov

Pharmacological management of sleep apnoea. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of inhaled fluticasone on upper airway during sleep and wakefulness in asthma: a pilot study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Intranasal corticosteroid therapy in the treatment of obstructive sleep apnea: A meta-analysis of randomized controlled trials. [2017]

5. United States 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. [2016]

6. New Zealand 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. [2022]

7. England 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. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical effect of montelukast sodium combined with inhaled corticosteroids in the treatment of OSAS children. [2021]