Clinical trial NCT05143502: Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.
Official title: Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Montelukast
Chronic Rhinosinusitis With Nasal Polyps
Keywords: Montelukast
Chronic Rhinosinusitis with Nasal Polyps
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

.

Eligibility criteria: 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.

Primary outcomes:
measure: Change at nasal polyp size
timeFrame: after 12 weeks from the start of treatment
Secondary outcomes:
measure: Nasal symptoms.
timeFrame: after 12 weeks from the start of treatment
measure: Radiological evaluation
timeFrame: after 12 weeks from the start of treatment
measure: Quality of life score
timeFrame: after 12 weeks from the start of treatment
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
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