drugset / Trial / NCT05143502
Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the work is to examine the efficacy of montelukast as an adjunct to steroid therapy in patients with chronic rhinosinusitis with nasal polyps.
Timeline
- Start
- 2022-01-01
- Primary completion
- 2024-01-01
- Completion
- 2024-03-01
Publications
- Background Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
- Background Langdon C, Mullol J. Nasal polyps in patients with asthma: prevalence, impact, and management challenges. J Asthma Allergy. 2016 Mar 14;9:45-53. doi: 10.2147/JAA.S86251. eCollection 2016.
- Background Johansson L, Akerlund A, Holmberg K, Melen I, Bende M. Prevalence of nasal polyps in adults: the Skovde population-based study. Ann Otol Rhinol Laryngol. 2003 Jul;112(7):625-9. doi: 10.1177/000348940311200709.
- Background Wang X, Zhang N, Bo M, Holtappels G, Zheng M, Lou H, Wang H, Zhang L, Bachert C. Diversity of TH cytokine profiles in patients with chronic rhinosinusitis: A multicenter study in Europe, Asia, and Oceania. J Allergy Clin Immunol. 2016 Nov;138(5):1344-1353. doi: 10.1016/j.jaci.2016.05.041. Epub 2016 Jul 15.
- Background Scadding GK, Durham SR, Mirakian R, Jones NS, Drake-Lee AB, Ryan D, Dixon TA, Huber PA, Nasser SM; British Society for Allergy and Clinical Immunology. BSACI guidelines for the management of rhinosinusitis and nasal polyposis. Clin Exp Allergy. 2008 Feb;38(2):260-75. doi: 10.1111/j.1365-2222.2007.02889.x. Epub 2007 Dec 20.
- Background Joe SA, Thambi R, Huang J. A systematic review of the use of intranasal steroids in the treatment of chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2008 Sep;139(3):340-7. doi: 10.1016/j.otohns.2008.05.628.
- Background Rudmik L, Schlosser RJ, Smith TL, Soler ZM. Impact of topical nasal steroid therapy on symptoms of nasal polyposis: a meta-analysis. Laryngoscope. 2012 Jul;122(7):1431-7. doi: 10.1002/lary.23259. Epub 2012 Mar 12.
- Background Fokkens W, Desrosiers M, Harvey R, Hopkins C, Mullol J, Philpott C, Alobid I, Anselmo-Lima WT, Bachert C, Baroody F, Bernal-Sprekelsen M, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Douglas R, Gevaert P, Hafner A, Hellings P, Joos G, Kalogjera L, Kern R, Knill A, Kocks J, Landis BN, Limpens J, Lebeer S, Lourenco O, Matricardi PM, Meco C, O Mahony L, Reitsma S, Ryan D, Schlosser R, Senior B, Smith T, Teeling T, Tomazic PV, Toppila-Salmi S, Wang DY, Wang D, Zhang L, Lund V. EPOS2020: development strategy and goals for the latest European Position Paper on Rhinosinusitis. Rhinology. 2019 Jun 1;57(3):162-168. doi: 10.4193/Rhin19.080.
- Background Holgate ST, Peters-Golden M, Panettieri RA, Henderson WR Jr. Roles of cysteinyl leukotrienes in airway inflammation, smooth muscle function, and remodeling. J Allergy Clin Immunol. 2003 Jan;111(1 Suppl):S18-34; discussion S34-6. doi: 10.1067/mai.2003.25.
- Background Cao Y, Wang J, Bunjhoo H, Xie M, Xu Y, Fang H. Comparison of leukotriene receptor antagonists in addition to inhaled corticosteroid and inhaled corticosteroid alone in the treatment of adolescents and adults with bronchial asthma: a meta-analysis. Asian Pac J Allergy Immunol. 2012 Jun;30(2):130-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Montelukast | Other / unclassified | 10 mg | Oral |
| Background | Fluticasone Furoate | Other / unclassified | 100 ug | Intranasal |
| Background | Prednisolone | Other / unclassified | 40 mg | Oral |