Steroid Treatment for Elimination of Rebound Obstruction From Intranasal Decongestants

Not Applicable

Recruiting

• Conditions: Nasal Obstruction; Chronic Rhinitis
• Interventions: Drug: Oxymetazoline + Triamcinolone

• Registration Number: NCT07168148
• Lead Sponsor: Washington University School of Medicine

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.

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.

Study Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study Start: 2025-09-09
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Titration	Oxymetazoline + Triamcinolone	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.

Primary Outcome Measures

Name	Time	Method
Responder rate	week 8	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.

Secondary Outcome Measures

Name	Time	Method
Responder rate among supratherapeutic users.	week 8	Responder rate among supratherapeutic users, will be defined as percentage of participants who started the study using topical decongestants more than twice per day and 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.
The rate of partial responders among supratherapeutic users	week 8	The rate of partial responders among supratherapeutic users will be defined as the percentage of supratherapeutic users who achieve a reduction in their usage of decongestants to twice daily by the end of the study.
Change in Nasal Obstruction Symptom Evaluation (NOSE)	through study completion, on average of 8 weeks	NOSE is a disease-specific survey designed to measure nasal obstruction. It consists of 5 questions, each rated on a scale of 0 to 4, and the total score represents the sum of the raw scores multiplied by 5. A score of 30 is considered indicative of clinically significant NAO.; Change in Nasal Obstruction Symptom Evaluation (NOSE) will be calculated as the difference in NOSE score at baseline minus NOSE score at the end of study participation.

Trial Locations

Locations (1)

Washington University; 🇺🇸 St Louis, Missouri, United States