Oxymetazoline + Corticosteroids for Nasal Congestion

(NORTOC Trial)

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

Trial Summary

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.

What data supports the effectiveness of the drug combination of Budesonide and Oxymetazoline 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 reducing nasal symptoms in conditions like perennial rhinitis and seasonal allergic rhinitis. ^{1 2 3 4 5}

Is the combination of Oxymetazoline and Budesonide safe for treating nasal congestion?

Budesonide, used in nasal sprays for conditions like rhinitis, has been generally well-tolerated in studies, with few serious side effects reported. Some adverse events like headache and blurred vision have been noted, but long-term use in some patients showed no serious adverse reactions. ^{3 6 7 8 9}

How does the drug oxymetazoline combined with budesonide differ from other treatments for nasal congestion?

The combination of oxymetazoline and budesonide offers a unique approach by providing faster relief of nasal blockage compared to budesonide alone, due to oxymetazoline's quick-acting decongestant properties. This combination is particularly effective in controlling nasal symptoms more rapidly, making it distinct from other treatments that may not offer the same speed of relief. ^{1 3 10 11 12}

What is the purpose of this trial?

This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. The investigators hypothesize that combination treatment with oxymetazoline and intranasal corticosteroid spray will provide a larger reduction in nasal obstruction than intranasal corticosteroid alone for patients suffering from chronic nasal obstruction, and there will not be occurrences of rhinitis medicamentosa.

Research Team

Nyssa F Farrell, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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, 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]

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]

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]

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 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]

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 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]

References

1. Thailand 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. [2016]

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

Vasoconstrictor and corticosteroid responsive components of allergic nasal mucosal swelling. [2004]

3. United States 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. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. [2006]

5. Denmark pubmed.ncbi.nlm.nih.gov

Reduction of metacholine-induced nasal secretion by treatment with a new topical steroid in perennial non-allergic rhinitis. [2019]

6. Denmark pubmed.ncbi.nlm.nih.gov

The effect of budesonide in perennial rhinitis. [2008]

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

Adverse events associated with budesonide nasal irrigation reported to the US Food and Drug Administration: 2007 to 2022. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

[A new method of administration of budesonide powder for the treatment of allergic rhinitis]. [2006]

9. United States 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. [2019]

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

Increased nasal airflow with budesonide compared with desloratadine during the allergy season. [2013]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Budesonide. A preliminary review of its pharmacodynamic properties and therapeutic efficacy in asthma and rhinitis. [2018]

12. England pubmed.ncbi.nlm.nih.gov

The pathophysiology and treatment of rhinitis medicamentosa. [2019]