Steroid Treatment for Elimination of Rebound Obstruction From Intranasal Decongestants

Purpose

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.

Conditions

  • Nasal Obstruction
  • Chronic Rhinitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. ) 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
prospective virtually administered
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Titration 		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.
  • 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.
    Other names:
    • Afrin + Nasacort

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University
St Louis 4407066, Missouri 4398678 63110
Contact:
Sara Kukuljan
314-362-7563
kukuljas@wustl.edu

More Details

NCT ID
NCT07168148
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Nyssa Farrell, MD
314-362-7509
nyssa.farrell@wustl.edu

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.