drugset / Trial / NCT07168148
Steroid Treatment for Elimination of Rebound Obstruction From Intranasal Decongestants
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-11-10
- Primary completion
- 2026-03-19
- Completion
- 2026-03-19
Publications
- Background Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007;19:23-34.
- Background 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.
- Background LAKE CF. Rhinitis medicamentosa. Proc Staff Meet Mayo Clin. 1946 Sep 18;21(19):367-71. No abstract available.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- 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.
- Background 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.
- Background Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Background 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.
- Results Graf P. Rhinitis medicamentosa: a review of causes and treatment. Treat Respir Med. 2005;4(1):21-9. doi: 10.2165/00151829-200504010-00003.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxymetazoline | Other / unclassified | 0 % | — |
| Subject | Oxymetazoline | Other / unclassified | 0.0125 % | — |
| Subject | Oxymetazoline | Other / unclassified | 0.025 % | — |
| Subject | Oxymetazoline | Other / unclassified | 0.0375 % | — |
| Subject | Oxymetazoline | Other / unclassified | 0.05 % | — |
| Background | Triamcinolone | Other / unclassified | — | Other |