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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.
Population and Methods The study will be conducted at the otorhinolaryngology department in Assiut University Hospital.
After fulfilling all inclusion and exclusion criteria all patients will be subjected to
A. Full history taking including :
B. Examination :
C. Investigations :
Multi-slice computer tomography (MSCT) of nose and paranasal sinuses axial, coronal and sagittal cuts without contrast .
D. Management :
Patients will be divided into 2 equal groups. Patients in group A will be treated with fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily plus oral montelukast (montelukast 10 mg, once a day) for 3 monthes and oral Prednisolone 40 mg/day for two weeks. Subjects in treatment group B will receive topical and systemic steroids in an identical regimen only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast Group | Experimental | Patients in group A (interventional group) will be treated with fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily plus oral montelukast (montelukast 10 mg, once a day) for 3 monthes and oral Prednisolone 40 mg/day for two weeks. |
|
| Control Group | Active Comparator | Subjects in treatment group B will receive topical and systemic steroids in an identical regimen only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | Montelukast is a leukotrienes antagonist which has proven efficacious in chronic inflammatory conditions of the airways, including allergic rhinitis, asthma, and aspirin-exacerbated respiratory disease (AERD), all diseases that often coexist with CRSwNP. We will use oral Montelukast (montelukast 10 mg, once a day) for 3 monthes |
| Measure | Description | Time Frame |
|---|---|---|
| Change at nasal polyp size | Each CRSwNP patient will undergo nasal endoscopy to score the polyp size (0-4) in both nasal cavities using a modified Lildholdt scoring system: 0 = no nasal polyps.
| after 12 weeks from the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal symptoms. | All participants will asked to score five sinonasal symptoms (nasal congestion/obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of smell, and facial pain) from 0 to 4. 0 = symptom-free/no symptom.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University Hospital | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22469599 | 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. | |
| 27042129 |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D011239 | Prednisolone |
| C523187 | fluticasone furoate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Prednisolone | Drug | Oral Prednisolone 40 mg/day for two weeks. |
|
| Fluticasone Furoate | Drug | fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily |
|
| after 12 weeks from the start of treatment |
| Radiological evaluation | CT scan of the nose and paranasal sinuses will performed to all patients before and after the treatment and staged using the Lund-Mackay (LMK) scoring system where each sinus (maxillar, anterior ethmoidal, posterior eth-moidal, frontal, esphenoidal) is scored for opacification (0, no opacity; 1, partial opacity; 2, total opacity), and the ostiomeatal complex is scored 0 (no obstruction) or 2 (obstruction). The uni-lateral score goes from 0 to 12 whereas the bilateral score goes from 0 to 24. | after 12 weeks from the start of treatment |
| Quality of life score | Subjects will complete validated questionnaire related to general quality of life lCSD (International Classification of Sinus Disease) before and after treatment. The ICSD records patients' symptoms of facial pain and pressure; headache ;nasal blockage Or congestion; nasal discharge; disturbance of smell; and Over all discomfort on a 0 to 10 ordinal scale. | after 12 weeks from the start of treatment |
| 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. |
| 12903683 | 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. |
| 27544740 | 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. |
| 18167126 | 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. |
| 18722209 | 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. |
| 22410935 | 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. |
| 30810118 | 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. |
| 12532084 | 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. |
| 22830292 | 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. |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |