Nasal Obstruction With Oxymetazoline and Corticosteroids

Phase 2

Recruiting

• Conditions: Nasal Obstruction
• Interventions: Drug: Oxymetazoline Nasal Spray; Drug: Budesonide nasal spray

• Registration Number: NCT06830109
• Lead Sponsor: Washington University School of Medicine

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.

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 Timeline

• Study Start: 2024-10-15
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
budesonide + oxymetazoline,	Oxymetazoline Nasal Spray	alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC).
budesonide + oxymetazoline,	Budesonide nasal spray	alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC).
budesonide	Budesonide nasal spray	intranasal corticosteroid that is available OTC.

Primary Outcome Measures

Name	Time	Method
Rate of Responders	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.

Secondary Outcome Measures

Name	Time	Method
Sino-Nasal Outcome Test (SNOT-22)	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.
Nasal Obstruction Symptom Evaluation (NOSE)	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.
Clinical Global Impression of Severity (CGI-S)	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.

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States