Nasal Obstruction With Oxymetazoline and Corticosteroids (NORTOC)

September 3, 2025 updated by: Nyssa Farrell, Washington University School of Medicine

Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: budesonide + oxymetazoline,
alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC).
Drug: Oxymetazoline Nasal Spray
Intra-nasal alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC)
Other Names:
  • Afrin (commercial name for oxymetazoline hydrochloride)
Drug: Budesonide nasal spray
Intranasal corticosteroid that is available over-the-counter (OTC)
Other Names:
  • Rhinocort (commercial name for budesonide)
Active Comparator: budesonide
intranasal corticosteroid that is available OTC.
Drug: Budesonide nasal spray
Intranasal corticosteroid that is available over-the-counter (OTC)
Other Names:
  • Rhinocort (commercial name for budesonide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Responders
Time Frame: 4 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sino-Nasal Outcome Test (SNOT-22)
Time Frame: baseline, 2 weeks, and 4 weeks

SNOT-22 is a 22-question survey designed to measure the physical, functional, and emotional consequences of rhinosinusitis. It contains questions regarding symptoms commonly associated with sinonasal disease.

Subjects rate each question by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT-22 total score ranges from a minimum score of 0 to a maximum score of 110, with higher scores representing worse outcome.
baseline, 2 weeks, and 4 weeks
Nasal Obstruction Symptom Evaluation (NOSE)
Time Frame: baseline, 2 weeks, 4 weeks
NOSE is a disease-specific survey designed to measure nasal obstruction. It consists of 5 questions, each rated on a scale of 0 to 4. The total score represents the sum of the raw scores multiplied by 5 and ranges from 0 to 100, with higher values indicating worse symptoms. A score of 30 is considered indicative of clinically significant nasal airway obstruction.
baseline, 2 weeks, 4 weeks
Clinical Global Impression of Severity (CGI-S)
Time Frame: baseline, week 4
The CGI-Severity Scale from 1 to 7 (1 is "Not Obstructed at All", 7 is "Completely Obstructed") provides the severity of nasal obstruction as perceived from the patient. Comparison of CGI-S scores at 4 weeks with baseline will help identify subjects that have experienced rebound congestion. The investigators will report the number of patients who report a worsening of their symptoms, as measured by a 1-point (1 category) increase in CGI-S scale at 4 weeks as compared to CGI-S scale at baseline.
baseline, week 4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression of Severity (CGI-S); experimental arm
Time Frame: baseline, week 7
The CGI-Severity Scale from 1 to 7 (1 is "Not Obstructed at All", 7 is "Completely Obstructed") provides the severity of nasal obstruction as perceived from the patient. Comparison of CGI-S scores at 7 weeks with baseline will help identify subjects in the experimental arm who struggled with discontinuation of oxymetazoline. The investigators will report the number of subjects who report a worsening of their symptoms, as measured by a 2-point (2 categories) increase in CGI-S scale at 7 weeks as compared to CGI-S scale at baseline in the experimental arm only.
baseline, week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Nyssa F Farrell, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202406175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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