Nasal Obstruction With Oxymetazoline and Corticosteroids

Summary

This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. The investigators hypothesize that combination treatment with oxymetazoline and intranasal corticosteroid spray will provide a larger reduction in nasal obstruction than intranasal corticosteroid alone for patients suffering from chronic nasal obstruction, and there will not be occurrences of rhinitis medicamentosa.

Timeline

Start

2024-10-15

Primary completion

2026-12-30

Completion

2026-12-30

Publications

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• Background Stewart M, Ferguson B, Fromer L. Epidemiology and burden of nasal congestion. Int J Gen Med. 2010 Apr 8;3:37-45. doi: 10.2147/ijgm.s8077.
• Background Thongngarm T, Assanasen P, Pradubpongsa P, Tantilipikorn P. The effectiveness of oxymetazoline plus intranasal steroid in the treatment of chronic rhinitis: A randomised controlled trial. Asian Pac J Allergy Immunol. 2016 Mar;34(1):30-7. doi: 10.12932/AP0649.34.1.2016.
• Background Calvo-Henriquez C, Viera-Artiles J, Rodriguez-Iglesias M, Rodriguez-Rivas P, Maniaci A, Yanez MM, Martinez-Capoccioni G, Alobid I. The Role of Corticosteroid Nasal Irrigations in the Management of Chronic Rhinosinusitis: A State-of-the-Art Systematic Review. J Clin Med. 2023 May 22;12(10):3605. doi: 10.3390/jcm12103605.
• 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 Graf P, Juto JE. Decongestion effect and rebound swelling of the nasal mucosa during 4-week use of oxymetazoline. ORL J Otorhinolaryngol Relat Spec. 1994 May-Jun;56(3):157-60. doi: 10.1159/000276633.
• Background Morris S, Eccles R, Martez SJ, Riker DK, Witek TJ. An evaluation of nasal response following different treatment regimes of oxymetazoline with reference to rebound congestion. Am J Rhinol. 1997 Mar-Apr;11(2):109-15. doi: 10.2500/105065897782537197.
• Background Kumar RS, Jain MK, Kushwaha JS, Patil S, Patil V, Ghatak S, Sanmukhani J, Mittal R. Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion. J Asthma Allergy. 2022 Jun 10;15:783-792. doi: 10.2147/JAA.S357288. eCollection 2022.
• Background Matreja PS, Gupta V, Kaur J, Singh S. Efficacy of fluticasone and oxymetazoline as the treatment for allergic rhinitis. J Clin Diagn Res. 2012;6(1):85-88.
• Background Meltzer EO, Bernstein DI, Prenner BM, Berger WE, Shekar T, Teper AA. Mometasone furoate nasal spray plus oxymetazoline nasal spray: short-term efficacy and safety in seasonal allergic rhinitis. Am J Rhinol Allergy. 2013 Mar-Apr;27(2):102-8. doi: 10.2500/ajra.2013.27.3864.
• Background Juvekar MR, Vaidya GK, Majumder A, Pendharkar AD, Irudhayarajan A, Kundu A, Ramesh D, Kumar JD, Jagannatha B, Mathew J, Nikam MP, Mehta M, Chawla N, Hajare P, Gowda PGC, Murthy PVLN, Mathew SM, Damle MV, Kant C, Nair AB, Jaiswal A, Mehta RT. A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis. Clin Drug Investig. 2024 Feb;44(2):123-130. doi: 10.1007/s40261-023-01338-8. Epub 2024 Jan 9.
• 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 Tait SD, Kallogjeri D, Chidambaram S, Schneider J, Piccirillo JF. Psychometric and Clinimetric Validity of the Modified 25-Item Sino-Nasal Outcome Test. Am J Rhinol Allergy. 2019 Sep;33(5):577-585. doi: 10.1177/1945892419851622. Epub 2019 May 28. No abstract available.
• Background Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
• 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.
• Background Taverner D, Bickford L, Shakib S, Tonkin A. Evaluation of the dose-response relationship for intra-nasal oxymetazoline hydrochloride in normal adults. Eur J Clin Pharmacol. 1999 Sep;55(7):509-13. doi: 10.1007/s002280050665.
• Background Akerlund A, Klint T, Olen L, Rundcrantz H. Nasal decongestant effect of oxymetazoline in the common cold: an objective dose-response study in 106 patients. J Laryngol Otol. 1989 Aug;103(8):743-6. doi: 10.1017/s0022215100109958.
• Background Druce HM, Ramsey DL, Karnati S, Carr AN. Topical nasal decongestant oxymetazoline (0.05%) provides relief of nasal symptoms for 12 hours. Rhinology. 2018 Dec 1;56(4):343-350. doi: 10.4193/Rhin17.150.
• Background Saratziotis A, Emanuelli E, Zanotti C, Mireas G, Pavlidis P, Ferfeli M, Hajiioannou J. Endoscopic sinus surgery outcomes in CRS: quality of life and correlations with NOSE scale in a prospective cohort study. Eur Arch Otorhinolaryngol. 2021 Apr;278(4):1059-1066. doi: 10.1007/s00405-020-06334-8. Epub 2020 Sep 8.
• Background Kandathil CK, Saltychev M, Abdelwahab M, Spataro EA, Moubayed SP, Most SP. Minimal Clinically Important Difference of the Standardized Cosmesis and Health Nasal Outcomes Survey. Aesthet Surg J. 2019 Jul 12;39(8):837-840. doi: 10.1093/asj/sjz070.
• Background Baroody FM, Brown D, Gavanescu L, DeTineo M, Naclerio RM. Oxymetazoline adds to the effectiveness of fluticasone furoate in the treatment of perennial allergic rhinitis. J Allergy Clin Immunol. 2011 Apr;127(4):927-34. doi: 10.1016/j.jaci.2011.01.037. Epub 2011 Mar 5.

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