Oxymetazoline + Corticosteroids for Nasal Congestion

(NORTOC Trial)

Recruiting at 1 trial location

Overseen By Sara Kukuljan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Sinonasal mass, Nasal polyps, Chronic sinusitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

Duration: 7 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a combination treatment using two nasal sprays, oxymetazoline and budesonide (a corticosteroid), for individuals with persistent nasal congestion unresponsive to standard treatments. Researchers believe this combination may relieve stuffy noses more effectively without causing rebound congestion. Individuals who have used other steroid sprays for at least a month without success and who either do not want or cannot undergo surgery may be suitable candidates. Participants must discontinue other nasal sprays and decongestants before joining. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants the potential benefit of an innovative approach.

Will I have to stop taking my current medications?

You must stop using any other nasal sprays, except saline, and oral decongestants before joining the trial. If you have used oxymetazoline or other nasal decongestants, you need to have stopped them 4 weeks before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using oxymetazoline with corticosteroids like budesonide is generally safe for treating nasal congestion. Studies have found that oxymetazoline can relieve congestion for up to 12 hours and improves breathing without major side effects. Budesonide, when used in nasal sprays, is also well-tolerated, with few serious side effects reported. One study found that using a similar combination for 20 days did not cause major side effects or lead to rebound congestion. This suggests the treatment is likely safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about combining budesonide with oxymetazoline for nasal congestion because this combo could offer faster relief. Most nasal congestion treatments rely on either corticosteroids like budesonide or decongestants like oxymetazoline separately. But combining them could provide the anti-inflammatory benefits of budesonide along with the immediate vasoconstriction effects of oxymetazoline. This dual action might not only relieve symptoms quicker but also sustain relief longer than using each drug alone.

What evidence suggests that this trial's treatments could be effective for chronic nasal obstruction?

This trial will compare the effectiveness of using oxymetazoline with budesonide versus budesonide alone for relieving nasal congestion. Research has shown that the combination of oxymetazoline and budesonide relieves stuffy noses faster than budesonide alone. This combination is particularly effective in reducing nasal blockage during the initial days of treatment. Studies also indicate that oxymetazoline, when combined with budesonide, significantly reduces nasal congestion over a longer period compared to a placebo. Evidence suggests this combination might be a better option for individuals with chronic nasal blockage that doesn't improve with standard treatments. ^{2 4 6 7 8}

Who Is on the Research Team?

Nyssa F Farrell, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults who've tried nasal steroids for at least a month without relief from chronic nasal obstruction. They should be able to understand English, not want or can't have surgery due to other health issues, and haven't used decongestants in the last 4 weeks. People with sinus tumors, polyps, chronic sinusitis, allergies to oxymetazoline, or conditions like pulmonary hypertension cannot join.

Inclusion Criteria

I used topical steroids daily for at least a month without improvement.

Ability to read, write, and understand English

I either don't want surgery or can't have it due to other health issues.

Exclusion Criteria

I have had a tumor in my nasal passages.

I have had nasal polyps in the past.

I have a long-term history of sinus infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oxymetazoline + budesonide or budesonide alone intranasal spray for 7 weeks

7 weeks

Questionnaires at baseline, Week 2, Week 4, Week 5, Week 6, and Week 7

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Budesonide
• Oxymetazoline

Trial Overview The study tests if using oxymetazoline (a nasal decongestant) with budesonide (a steroid spray) is more effective than just budesonide alone for long-term management of stubborn nasal blockage. It aims to prove that this combination won't lead to medication-induced rhinitis.

How Is the Trial Designed?

Group I: budesonide + oxymetazoline, Experimental Treatment 2 Interventions

alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC).

Group II: budesonide Active Control 1 Intervention

intranasal corticosteroid that is available OTC.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

In a study of 61 patients with seasonal allergic rhinitis, both desloratadine and budesonide significantly improved nasal peak inspiratory flow (NPIF) compared to baseline, but budesonide was more effective overall, showing a greater increase in NPIF during the treatment period.

Both treatments also led to significant reductions in nasal symptoms and improved quality of life, although the subjective symptom scores did not differ significantly between the two treatments, likely due to factors like small sample size and low pollen counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased nasal airflow with budesonide compared with desloratadine during the allergy season. Bhatia, S., Baroody, FM., deTineo, M., et al.[2013]

In a study involving 202 children aged 6 to 16 with perennial allergic rhinitis, budesonide aqueous nasal spray at a dose of 128 microg once daily was significantly more effective than placebo in improving nasal airflow and reducing symptoms within the first 12 hours.

Budesonide also led to a decrease in eosinophils, which are associated with allergic reactions, and reduced the need for rescue medication, indicating its efficacy in managing allergic rhinitis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide aqueous nasal spray is an effective treatment in children with perennial allergic rhinitis, with an onset of action within 12 hours. Fokkens, WJ., Cserháti, E., dos Santos, JM., et al.[2019]

In a study involving 635 adults with seasonal allergic rhinitis, both budesonide and fluticasone propionate nasal sprays were effective in reducing symptoms, with budesonide at 256 micrograms/day showing superior efficacy, particularly in reducing sneezing and runny nose during high pollen counts.

The higher dose of budesonide (256 micrograms/day) led to substantial or total symptom control in 88.4% of patients, compared to 81.9% for fluticasone propionate, while all treatments had a low incidence of adverse events, indicating they were well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of aqueous suspensions of budesonide nasal spray (128 micrograms and 256 micrograms once daily) and fluticasone propionate nasal spray (200 micrograms once daily) in the treatment of adult patients with seasonal allergic rhinitis. Stern, MA., Dahl, R., Nielsen, LP., et al.[2019]

In a study of 142 adult patients with perennial rhinitis, budesonide nasal aerosol significantly reduced nasal symptoms compared to terfenadine, indicating its superior efficacy in managing this condition.

Budesonide combined with oxymetazoline provided faster relief of nasal blockage than budesonide alone, highlighting the potential benefits of combination therapy for quicker symptom control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical comparison of budesonide nasal aerosol, terfenadine and a combined therapy of budesonide and oxymetazoline in adult patients with perennial rhinitis. Lau, SK., Wei, WI., Van Hasselt, CA., et al.[2016]

In a study of 10 patients with rhinitis medicamentosa, treatment with budesonide nasal spray for 6 weeks allowed all participants to successfully discontinue their use of topical vasoconstrictors.

The findings suggest that rebound swelling in rhinitis medicamentosa is primarily caused by interstitial edema rather than vasodilation, highlighting the importance of understanding the underlying mechanisms of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pathophysiology and treatment of rhinitis medicamentosa. Graf, P., Hallén, H., Juto, JE.[2019]

Budesonide, a non-halogenated steroid nasal spray, demonstrated a significant and dose-dependent reduction in nasal symptoms such as blockage, discharge, and sneezing in a study of 36 patients with perennial rhinitis.

Long-term use of budesonide (over two years) showed no serious adverse reactions, and monitoring of hematologic parameters and adrenal function indicated it is safe for extended treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of budesonide in perennial rhinitis. Balle, VH.[2008]

In a study of 29 asymptomatic patients, it was found that oxymetazoline spray alone could not fully relieve nasal congestion during ragweed season, indicating limitations of topical vasoconstrictors.

Treatment with oral methylprednisolone significantly improved nasal congestion, suggesting that corticosteroids can address non-vascular components of inflammation, enhancing the effectiveness of vasoconstrictors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vasoconstrictor and corticosteroid responsive components of allergic nasal mucosal swelling. Brooks, CD., Titus, CR., Heissler, CT.[2004]

In a study of 22 patients with perennial non-allergic rhinitis, budesonide treatment did not significantly reduce nasal airway resistance compared to placebo, indicating limited efficacy in that specific measure.

However, budesonide effectively reduced eosinophilia in nasal smears and significantly improved symptoms such as nasal obstruction, secretion, and sneezing, demonstrating its therapeutic benefits despite the lack of effect on airway resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of metacholine-induced nasal secretion by treatment with a new topical steroid in perennial non-allergic rhinitis. Malm, L., Wihl, JA., Lamm, CJ., et al.[2019]

Budesonide is an effective inhaled corticosteroid for managing asthma, showing similar efficacy to beclomethasone dipropionate at conventional doses (200 to 800 micrograms/day) and superior control compared to oral prednisone in severe asthma cases.

In addition to asthma treatment, intranasal budesonide effectively relieves nasal symptoms in allergic rhinitis, demonstrating comparable efficacy to other intranasal corticosteroids while having minimal systemic side effects and little impact on adrenal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide. A preliminary review of its pharmacodynamic properties and therapeutic efficacy in asthma and rhinitis. Clissold, SP., Heel, RC.[2018]

In a study involving 66 patients with allergic rhinitis, a new device for administering powdered budesonide was found to be as effective as a standard aerosol treatment in controlling symptoms, with both showing significant efficacy (p < 0.01).

Patients reported a significantly better overall experience with the powdered budesonide treatment compared to the standard aerosol, indicating improved acceptance and slightly better tolerance of the new delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new method of administration of budesonide powder for the treatment of allergic rhinitis]. Soler, R., Mas, S., Pineda, J., et al.[2006]

From 2007 to 2022, the FDA received 119 reports regarding the off-label use of budesonide nasal irrigation, primarily from patients.

Adverse events associated with this usage included headaches, difficulty breathing (dyspnea), and blurred vision, highlighting potential safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with budesonide nasal irrigation reported to the US Food and Drug Administration: 2007 to 2022. Rathi, VK., Sawicki, NW., Schlosser, RJ., et al.[2023]

Budesonide in an aqueous nasal spray (BANS) significantly reduced symptoms of chronic rhinosinusitis in a study of 167 patients, showing greater improvement in symptom scores compared to placebo over 20 weeks.

BANS was particularly effective in allergic patients, improving nasal congestion and discharge, and enhancing the sense of smell, while also increasing peak nasal inspiratory flow in both allergic and non-allergic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Lund, VJ., Black, JH., Szabó, LZ., et al.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06830109

Nasal Obstruction With Oxymetazoline and Corticosteroids This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/1709020/

A clinical comparison of budesonide nasal aerosol ... Budesonide with oxymetazoline for the first three days showed a faster relief of nasal blockage than budesonide alone (p less than 0.05). Mild and transient ...

3. withpower.com withpower.com/trial/phase-2-nasal-obstruction-9-2024-b16af

Oxymetazoline + Corticosteroids for Nasal Congestion Research shows that using Budesonide with Oxymetazoline provides faster relief of nasal blockage compared to Budesonide alone, and Budesonide is effective in ...

4. apjai-journal.org apjai-journal.org/wp-content/uploads/2016/10/29567-38527-4-PB.pdf

The effectiveness of oxymetazoline plus intranasal steroid ... Results: Oxymet significantly reduced nasal congestion in subjects with chronic rhinitis compared with placebo on the day of 15-28 and. 29-42. In subjects with ...

5. cmro.in cmro.in/index.php/jcmro/article/download/1023/1030/3097

A Closer Look at the Evidence Supporting Appropriate Use ... showed that using oxymetazoline (two sprays per nostril, twice-daily) with budesonide and cetirizine significantly reduced nasal congestion and.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3651108/

Oxymetazoline Hydrochloride Combined With Mometasone ... MNS plus OXY combination for 20 days decreases NC and improves activity QOL indicators without significant side effects or risk for RM.

7. go.drugbank.com go.drugbank.com/drugs/DB00935

Oxymetazoline: Uses, Interactions, Mechanism of Action When sprayed intranasally, oxymetazoline relieved relief nasal congestion and improved nasal airflow in patients with acute coryzal rhinitis for up to 12 hours ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2022/213872Orig1s000IntegratedR.pdf

213872Orig1s000 - accessdata.fda.gov The proposed OTC indication — temporarily relieves these following symptoms due to hay fever or other respiratory allergies: nasal congestion, runny nose, ...