Nasal Obstruction With Oxymetazoline and Corticosteroids (NORTOC)

The Washington University

Status and phase: Enrolling; Phase 2

Conditions: Nasal Obstruction

Treatments: Drug: Oxymetazoline Nasal Spray; Drug: Budesonide nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT06830109

202406175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

budesonide + oxymetazoline,

Experimental group

Description:

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

Treatment:

Drug: Budesonide nasal spray

Drug: Oxymetazoline Nasal Spray

budesonide

Active Comparator group

Description:

intranasal corticosteroid that is available OTC.

Treatment:

Drug: Budesonide nasal spray