RecruitingPhase 2NCT06830109

Nasal Obstruction With Oxymetazoline and Corticosteroids

Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids


Sponsor

Washington University School of Medicine

Enrollment

80 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • males and females ages 18 years or older
  • have a history of nasal obstruction
  • have failed a trial of topical steroids (that included at least 1 month of daily use)
  • ability to read, write, and understand English
  • either do not desire surgery or are poor surgical candidates due to medical comorbidities.
  • Patients who have had prior use of oxymetazoline or other nasal decongestants are eligible for the study but must have stopped usage 4 weeks prior to randomization.
  • Must be willing to stop using any other nasal sprays, besides saline, and oral decongestants.

Exclusion Criteria5

  • Any history of sinonasal mass/tumor
  • Any history of nasal polyps
  • a known history of chronic sinusitis
  • an allergy to oxymetazoline
  • or who have any medical contraindication to oxymetazoline use, such as pulmonary hypertension.

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Interventions

DRUGOxymetazoline Nasal Spray

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

DRUGBudesonide nasal spray

Intranasal corticosteroid that is available over-the-counter (OTC)


Locations(1)

Washington University

St Louis, Missouri, United States

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NCT06830109