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Clinical Trial 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.


Clinical Trial Description

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 : 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. . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05143502
Study type Interventional
Source Assiut University
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date January 1, 2022
Completion date March 1, 2024

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