Steroid Treatment for Elimination of Rebound Obstruction From Intranasal Decongestants
NCT ID: NCT07168148
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-11-10
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Nyssa Farrell, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. 2013 Sep-Oct;15(5):358-61. doi: 10.1001/jamafacial.2013.344.
Graf P. Rhinitis medicamentosa: a review of causes and treatment. Treat Respir Med. 2005;4(1):21-9. doi: 10.2165/00151829-200504010-00003.
Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007;19:23-34.
Mehuys E, Gevaert P, Brusselle G, Van Hees T, Adriaens E, Christiaens T, Van Bortel L, Van Tongelen I, Remon JP, Boussery K. Self-medication in persistent rhinitis: overuse of decongestants in half of the patients. J Allergy Clin Immunol Pract. 2014 May-Jun;2(3):313-9. doi: 10.1016/j.jaip.2014.01.009. Epub 2014 Mar 29.
LAKE CF. Rhinitis medicamentosa. Proc Staff Meet Mayo Clin. 1946 Sep 18;21(19):367-71. No abstract available.
Feinberg AR, Feinberg SM. The "nose drop nose" due to oxymetazoline (Afrin) and other topical vasoconstrictors. IMJ Ill Med J. 1971 Jul;140(1):50-2. No abstract available.
Hallen H, Enerdal J, Graf P. Fluticasone propionate nasal spray is more effective and has a faster onset of action than placebo in treatment of rhinitis medicamentosa. Clin Exp Allergy. 1997 May;27(5):552-8.
Ferguson BJ, Paramaesvaran S, Rubinstein E. A study of the effect of nasal steroid sprays in perennial allergic rhinitis patients with rhinitis medicamentosa. Otolaryngol Head Neck Surg. 2001 Sep;125(3):253-60. doi: 10.1067/mhn.2001.117717.
Scadding GK. Rhinitis medicamentosa. Clin Exp Allergy. 1995 May;25(5):391-4. doi: 10.1111/j.1365-2222.1995.tb01068.x. No abstract available.
Vaidyanathan S, Williamson P, Clearie K, Khan F, Lipworth B. Fluticasone reverses oxymetazoline-induced tachyphylaxis of response and rebound congestion. Am J Respir Crit Care Med. 2010 Jul 1;182(1):19-24. doi: 10.1164/rccm.200911-1701OC. Epub 2010 Mar 4.
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.
Afrin Addicts. [ca. 2024]. In Facebook [Group page]. Retrieved September 4, 2024, from https://www.facebook.com/groups/1551311815137595
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.
Elwany SS, Stephanos WM. Rhinitis medicamentosa. An experimental histopathological and histochemical study. ORL J Otorhinolaryngol Relat Spec. 1983;45(4):187-94. doi: 10.1159/000275642.
Elwany S, Abdel-Salaam S. Treatment of rhinitis medicamentosa with fluticasone propionate--an experimental study. Eur Arch Otorhinolaryngol. 2001 Mar;258(3):116-9. doi: 10.1007/s004050000309.
Knipping S, Holzhausen HJ, Goetze G, Riederer A, Bloching MB. Rhinitis medicamentosa: electron microscopic changes of human nasal mucosa. Otolaryngol Head Neck Surg. 2007 Jan;136(1):57-61. doi: 10.1016/j.otohns.2006.08.025.
Lin CY, Cheng PH, Fang SY. Mucosal changes in rhinitis medicamentosa. Ann Otol Rhinol Laryngol. 2004 Feb;113(2):147-51. doi: 10.1177/000348940411300213.
Cam B, Sari M, Midi A, Gergin O. Xylitol treats nasal mucosa in rhinitis medicamentosa: an experimental rat model study. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3123-3130. doi: 10.1007/s00405-019-05605-3. Epub 2019 Aug 29.
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.
Tas A, Yagiz R, Yalcin O, Uzun C, Huseyinova G, Adali MK, Karasalihoglu AR. Use of mometasone furoate aqueous nasal spray in the treatment of rhinitis medicamentosa: an experimental study. Otolaryngol Head Neck Surg. 2005 Apr;132(4):608-12. doi: 10.1016/j.otohns.2005.01.010.
Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
Other Identifiers
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202501224
Identifier Type: -
Identifier Source: org_study_id
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