Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.
NCT ID: NCT05143502
Last Updated: 2022-03-18
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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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2022-01-01
2024-03-01
Brief Summary
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Detailed Description
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* Study design: prospective randomized controlled trial.
* .
* Methodology:
After fulfilling all inclusion and exclusion criteria all patients will be subjected to
A. Full history taking including :
1. Personal History
2. History of sinonasal symptoms (nasal obstruction, nasal discharge, headache, hyposmia, sneezing, itching, facial pain…etc)
3. History of nasal surgery.
4. Other ENT symptoms
5. General symptoms suggestive of atopy
6. History of general medical illness.
B. Examination :
* 1\. General examination.
* 2\. Full ENT examination.
* 3\. Nasal endoscopy.
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.
.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Montelukast Group
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.
Montelukast
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
Prednisolone
Oral Prednisolone 40 mg/day for two weeks.
Fluticasone Furoate
fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily
Control Group
Subjects in treatment group B will receive topical and systemic steroids in an identical regimen only.
Prednisolone
Oral Prednisolone 40 mg/day for two weeks.
Fluticasone Furoate
fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily
Interventions
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Montelukast
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
Prednisolone
Oral Prednisolone 40 mg/day for two weeks.
Fluticasone Furoate
fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily
Eligibility Criteria
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Inclusion Criteria
* 2- Bilateral denovo nasal polyps confirmed by nasal endoscopy and CT scan.
Exclusion Criteria
* 2- Patient with unilateral nasal polyp.
* 3- Revision cases (history of previous surgical treatment).
* 4- Patient with fungal rhinosinusitis..
* 5- Pregnancy and lactation.
* 6- Malignancies.
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Hossam Aldein Samir Abd Elazeem Mohammed
Residant
Locations
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Assiut University Hospital
Asyut, , Egypt
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Montelukast in nasal polyps
Identifier Type: -
Identifier Source: org_study_id
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