Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05143502
Status:
UNKNOWN
Last Update Posted:
2022-03-18
First Post:
2021-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: