Nasal Obstruction With Oxymetazoline and Corticosteroids

Last updated: March 19, 2025
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

2

Condition

Acute Rhinitis

Nasal Obstruction

Treatment

Oxymetazoline Nasal Spray

budesonide

Budesonide nasal spray

Clinical Study ID

NCT06830109
202406175
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. males and females ages 18 years or older

  2. have a history of nasal obstruction

  3. have failed a trial of topical steroids (that included at least 1 month of dailyuse)

  4. ability to read, write, and understand English

  5. either do not desire surgery or are poor surgical candidates due to medicalcomorbidities.

  6. Patients who have had prior use of oxymetazoline or other nasal decongestants areeligible for the study but must have stopped usage 4 weeks prior to randomization.

  7. Must be willing to stop using any other nasal sprays, besides saline, and oraldecongestants.

Exclusion

Exclusion Criteria:

  1. Any history of sinonasal mass/tumor

  2. Any history of nasal polyps

  3. a known history of chronic sinusitis

  4. an allergy to oxymetazoline

  5. or who have any medical contraindication to oxymetazoline use, such as pulmonaryhypertension.

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: Oxymetazoline Nasal Spray
Phase: 2
Study Start date:
October 15, 2024
Estimated Completion Date:
July 30, 2025

Study Description

Participants will be directed to apply the intranasal spray, at a dosage of two sprays in each nostril, twice daily. The total treatment time for participants in both trial arms is 7 weeks. Participants will be randomized to either 1) oxymetazoline + budesonide intranasal spray or 2) budesonide intranasal spray. Participants will be mailed the intranasal spray directly from the pharmacy. Participants will complete questionnaires via REDCap survey link at baseline, Week 2, Week 4, Week 5, Week 6, and Week 7. A group of 10 participants will be asked to have nasal mucosal biopsies done at baseline and between weeks 4 and 6.

Connect with a study center

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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