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

Assiut University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Montelukast; Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: Fluticasone Furoate; Drug: Prednisolone; Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT05143502

Montelukast in nasal polyps

Details and patient eligibility

About

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.

Full 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.

.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Montelukast Group

Experimental group

Description:

Patients in group A (interventional group) 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.

Treatment:

Drug: Fluticasone Furoate

Drug: Montelukast

Drug: Prednisolone

Control Group

Active Comparator group

Description:

Subjects in treatment group B will receive topical and systemic steroids in an identical regimen only.

Treatment:

Drug: Fluticasone Furoate

Drug: Prednisolone