Steroid Treatment for Elimination of Rebound Obstruction From Intranasal Decongestants (STEROID)

The Washington University

Status and phase: Enrolling; Phase 2

Conditions: Nasal Obstruction; Chronic Rhinitis

Treatments: Drug: Oxymetazoline + Triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT07168148

202501224

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

2) have a history of chronic nasal obstruction 3) at least daily topical decongestant usage for at least 3 months 4) ability to read, write, and understand English.

Exclusion criteria

1. Any history of sinonasal mass/tumor

2. Any history of nasal polyps

3. Septal perforation

4. A diagnosis of one of the following conditions:

   1. eosinophilic granulomatosis with polyangiitis
   2. granulomatosis with polyangiitis

5. Any current intranasal drug use such as cocaine.

6. If they are currently using or have used intranasal steroid medications (oral or nasal) besides oxymetazoline for the past month.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Titration

Experimental group

Description:

Participants will begin the trial by providing their average daily usage of oxymetazoline. They will then be stratified according to this usage and placed into a titration schedule. 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 lower titration level. 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.

Treatment:

Drug: Oxymetazoline + Triamcinolone