NCT05143502

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. .

Conditions

• Montelukast
• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DRUG	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
DRUG	Prednisolone	Oral Prednisolone 40 mg/day for two weeks.
DRUG	Fluticasone Furoate	fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-01-01
• Completion: 2024-03-01
• First posted: 2021-12-03
• Last updated: 2022-03-18

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study