Nasal Obstruction With Oxymetazoline and Corticosteroids

NCT06830109 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202406175
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Oxymetazoline; Corticosteroids; Chronic rhinitis

Outcome Measures

Primary Outcomes (1)

• Rate of Responders

  The primary outcome measure will be the rate of responders (as a percentage) to the intervention defined as the number of participants reporting 2 (Moderately Improved), or 3 (Much Improved) in the Clinical Global Impression of Improvement (CGI-I) assessed after 4 weeks of treatment divided by the total number of participants in each study group. CGI-I asks subjects to rate their overall response to treatment using a 7-point Likert scale ranging from -3 to 3 ("Much Worse" to "Much Improved"). Participants responding 2 (Moderately Improved), or 3 (Much Improved) to the the CGI-I question "Compared to the start of the study, how would you rate your nasal breathing now", will be defined as responders to treatment.

  4 weeks

Secondary Outcomes (3)

• Sino-Nasal Outcome Test (SNOT-22)

  baseline, 2 weeks, and 4 weeks

• Nasal Obstruction Symptom Evaluation (NOSE)

  baseline, 2 weeks, 4 weeks

• Clinical Global Impression of Severity (CGI-S)

  baseline, week 4

Other Outcomes (1)

• Clinical Global Impression of Severity (CGI-S); experimental arm

  baseline, week 7

Study Arms (2)

budesonide + oxymetazoline,

EXPERIMENTAL

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

Drug: Oxymetazoline Nasal Spray; Drug: Budesonide nasal spray

budesonide

ACTIVE COMPARATOR

intranasal corticosteroid that is available OTC.

Drug: Budesonide nasal spray

Interventions

Oxymetazoline Nasal Spray DRUG

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

Also known as: Afrin (commercial name for oxymetazoline hydrochloride)

budesonide + oxymetazoline,

Budesonide nasal spray DRUG

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

Also known as: Rhinocort (commercial name for budesonide)

budesonide; budesonide + oxymetazoline,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (28)

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  BACKGROUND

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MeSH Terms

Conditions

Nasal Obstruction

Interventions

Oxymetazoline; Budesonide

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nyssa F Farrell, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nyssa Farrell, MD

CONTACT

314-362-7509; nyssa.farrell@wustl.edu

Sara Kukuljan

CONTACT

314-362-7563; kukuljas@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant and the research team will be unaware of the participant's intervention assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otolaryngology-Head & Neck Surgery

Model Details: Single-center, double-blinded, randomized, controlled trial conducted at Washington University School of Medicine

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: October 15, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)