Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.

Study Overview
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Brief Summary
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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.

Detailed Description
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Population and Methods The study will be conducted at the otorhinolaryngology department in Assiut University Hospital. 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 : Personal History History of sinonasal symptoms (nasal obstruction, nasal discharge, headache, hyposmia, sneezing, itching, facial pain…etc) History of nasal surgery. Other ENT symptoms General symptoms suggestive of atopy 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. .

Official Title
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Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.

Conditions
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Montelukast, Chronic Rhinosinusitis With Nasal Polyps

Intervention / Treatment
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* Drug: Montelukast
* Drug: Prednisolone
* Drug: Fluticasone Furoate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1- Adult patients (aged 18 years and over) 2- Bilateral denovo nasal polyps confirmed by nasal endoscopy and CT scan. Exclusion Criteria: - 1- CRS patients without nasal polyposis. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast Group<br>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. | Drug: Montelukast<br>* 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<br>Drug: Prednisolone<br>* Oral Prednisolone 40 mg/day for two weeks.<br>Drug: Fluticasone Furoate<br>* fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily<br>|
| Active Comparator: Control Group<br>Subjects in treatment group B will receive topical and systemic steroids in an identical regimen only. | Drug: Prednisolone<br>* Oral Prednisolone 40 mg/day for two weeks.<br>Drug: Fluticasone Furoate<br>* fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. small nasal polyps not reaching the inferior border of the middle turbinate. nasal polyps reaching beyond the inferior border of the middle turbinate. large nasal polyps reaching the lower edge of the inferior turbinate very large nasal polyps in contact with the floor of the nasal cavity. | after 12 weeks from the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | 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. mild symptom. moderate symptom. severe symptom. very severe symptom. This score will be assessed at the screening visit and follow-up visits at 4, 8 and 12 weeks. The total five-symptom score (T5SS) obtained with the sum of the individual symptoms (0-20). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Montelukast, Chronic Rhinosinusitis with Nasal Polyps