NCT07168148

Steroid Treatment for Elimination of Rebound Obstruction From Intranasal Decongestants

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, virtually administered trial conducted throughout the United States aims to evaluate a standardized protocol including the serial dilution of topical decongestants with concurrent topical steroids (triamcinolone), for elimination of dependence on topical decongestants.

Detailed description

Participants will begin the trial by providing their average daily usage of oxymetazoline. They will then be stratified according to this usage and will be placed into a titration schedule. In the first week of the trial they will continue their usage of oxymetazoline plus twice daily triamcinolone intranasal spray. Continuing twice daily triamcinolone intranasal spray, the oxymetazoline dosage will be decreased each week until it matches the triamcinolone frequency. Each week following this point the subjects will continue with a mixture of different concentrations of oxymetazoline till complete elimination. The maximum treatment time for participants who start the trial in the highest frequency oxymetazoline use group (greater than or equal to 5 times per day) would be 8 weeks. After a week on a given titration level, they will be assessed for severity of nasal obstruction and, if controlled, they will progress to the next titration.

Conditions

• Nasal Obstruction
• Chronic Rhinitis

Interventions

Type	Name	Description
DRUG	Oxymetazoline + Triamcinolone	Participants will be stratified according to this usage and placed into a titration schedule. * Titration 1: 0.05% 5x/day, * Titration 2: 0.05% 4x/day, * Titration 3: 0.05 3x/day, * Titration 4: 0.05% 2x/day. Participants with twice daily use, will then be placed in a titration schedule for oxymetazoline concentration which will stop when the oxymetazoline concentration is set to zero. * Titration 5: 0.0375% Afrin/Nasacort 2x/day, * Titration 6: 0.025% Afrin/Nasacort 2x/day, * Titration 7: 0.0125% Afrin/Nasacort 2x/day, * Titration 8: 0.0% Afrin/Nasacort 2x/day.

Timeline

• Start date: 2025-11-10
• Primary completion: 2026-03-19
• Completion: 2026-03-19
• First posted: 2025-09-11
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study