Recruiting
Phase 2

Oxymetazoline & Corticosteroids

Sponsor:

Washington University School of Medicine

Code:

NCT06830109

Conditions

Nasal Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oxymetazoline Nasal Spray

Budesonide nasal spray

Study Details

Brief 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.

Conditions

Nasal Obstruction

Study ID

NCT06830109

Start date

Oct 15, 2024

Status verified date

Sep, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 daily use)
4. ability to read, write, and understand English
5. either do not desire surgery or are poor surgical candidates due to medical comorbidities.
6. 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.

1. Must be willing to stop using any other nasal sprays, besides saline, and oral decongestants.

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 pulmonary hypertension.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: budesonide + oxymetazoline,

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

active comparator: budesonide

intranasal corticosteroid that is available OTC.

Interventions

Oxymetazoline Nasal Spray

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

Budesonide nasal spray

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

Primary outcome measure

  • Rate of Responders [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

More Information

Sponsor

Washington University School of Medicine

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • Oxymetazoline
  • Corticosteroids
  • Chronic rhinitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-09-11.