NCT06830109

Nasal Obstruction With Oxymetazoline and Corticosteroids

Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasal Obstruction

Interventions

Type	Name	Description
DRUG	Oxymetazoline Nasal Spray	Intra-nasal alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC)
DRUG	Budesonide nasal spray	Intranasal corticosteroid that is available over-the-counter (OTC)

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-02-17
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study