Steroid Treatment for Elimination of Rebound Obstruction From Intranasal Decongestants

NCT07168148 | Terminated Phase 2 FDA Drug

• 1 other identifier: 202501224
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasal Obstruction; Chronic Rhinitis

Keywords

topical intranasal corticosteroid management; nasal airway evaluation; triamcinolone; oxymetazoline

Outcome Measures

Primary Outcomes (1)

• Responder rate

  The primary outcome measure will be the responder rate, defined as the percentage of participants who are able to discontinue decongestant use by the end of the study period and report that their symptoms are well-controlled, indicated by a score of 4 or less on the CGI-S.

  week 8

Secondary Outcomes (3)

• Responder rate among supratherapeutic users.

  week 8

• The rate of partial responders among supratherapeutic users

  week 8

• Change in Nasal Obstruction Symptom Evaluation (NOSE)

  through study completion, on average of 8 weeks

Study Arms (1)

Titration

EXPERIMENTAL

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

Interventions

Oxymetazoline + Triamcinolone DRUG

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.

Also known as: Afrin + Nasacort

Titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• Any history of sinonasal mass/tumor
• Any history of nasal polyps
• Septal perforation
• A diagnosis of one of the following conditions:
• eosinophilic granulomatosis with polyangiitis
• granulomatosis with polyangiitis
• Any current intranasal drug use such as cocaine.
• If they are currently using or have used intranasal steroid medications (oral or nasal) besides oxymetazoline for the past month.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (21)

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  PMID: 17153005 BACKGROUND

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  PMID: 24811023 BACKGROUND

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  PMID: 20274226 BACKGROUND

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  PMID: 4104967 BACKGROUND

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  PMID: 20203244 BACKGROUND

• Graedon, Terry. "How to Beat Nose Spray Dependence One Nostril at a Time." Https://Www.Peoplespharmacy.Com/, The People's Pharmacy, 27 Mar. 2023, www.peoplespharmacy.com/articles/how-to-beat-nose-spray-dependence-one- nostril-at-a-time.

  BACKGROUND

• Afrin Addicts. [ca. 2024]. In Facebook [Group page]. Retrieved September 4, 2024, from https://www.facebook.com/groups/1551311815137595

  BACKGROUND

• Park SSE, Barmettler A. Vision Loss Secondary to Facial and Periorbital Steroid Injection: A Systematic Review. Ophthalmic Plast Reconstr Surg. 2021 Nov-Dec 01;37(6):511-521. doi: 10.1097/IOP.0000000000001910.

  PMID: 33481540 BACKGROUND

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  PMID: 6192384 BACKGROUND

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  PMID: 11374251 BACKGROUND

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  PMID: 17210334 BACKGROUND

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  PMID: 14994772 BACKGROUND

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  PMID: 31468129 BACKGROUND

• Suh SH, Chon KM, Min YG, Jeong CH, Hong SH. Effects of topical nasal decongestants on histology of nasal respiratory mucosa in rabbits. Acta Otolaryngol. 1995 Sep;115(5):664-71. doi: 10.3109/00016489509139384.

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• Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

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  PMID: 15725047 RESULT

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Oxymetazoline; Triamcinolone

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nyssa Farrell, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective virtually administered

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: September 11, 2025
• Study Start: November 10, 2025
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)