Nasal Obstruction With Oxymetazoline and Corticosteroids
Purpose
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.
Condition
- Nasal Obstruction
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Single-center, double-blinded, randomized, controlled trial conducted at Washington University School of Medicine
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- The participant and the research team will be unaware of the participant's intervention assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental budesonide + oxymetazoline, |
alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC). |
|
|
Active Comparator budesonide |
intranasal corticosteroid that is available OTC. |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06830109
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
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.