Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05143502
Brief 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.
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Study:
NCT05143502
Study Brief:
Protocol Section:
NCT05143502