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

Sponsor

Assiut University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05143502

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Montelukast Chronic Rhinosinusitis With Nasal Polyps	Drug: Montelukast Drug: Prednisolone Drug: Fluticasone Furoate	Phase 1/Phase 2

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 :

Personal History
History of sinonasal symptoms (nasal obstruction, nasal discharge, headache, hyposmia, sneezing, itching, facial pain…etc)
History of nasal surgery.
Other ENT symptoms
General symptoms suggestive of atopy
History of general medical illness.

B. Examination :

1. General examination.
1. Full ENT examination.
1. 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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Montelukast Group 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.	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
Active Comparator: Control Group Subjects in treatment group B will receive topical and systemic steroids in an identical regimen only.	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

Arm

Intervention/Treatment

Experimental: Montelukast Group

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.

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

Active Comparator: Control Group

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

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

Outcome Measures

Primary Outcome Measures

Change at nasal polyp size [after 12 weeks from the start of treatment]
Each CRSwNP patient will undergo nasal endoscopy to score the polyp size (0-4) in both nasal cavities using a modified Lildholdt scoring system: 0 = no nasal polyps. small nasal polyps not reaching the inferior border of the middle turbinate. nasal polyps reaching beyond the inferior border of the middle turbinate. large nasal polyps reaching the lower edge of the inferior turbinate very large nasal polyps in contact with the floor of the nasal cavity.

Secondary Outcome Measures

Nasal symptoms. [after 12 weeks from the start of treatment]
All participants will asked to score five sinonasal symptoms (nasal congestion/obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of smell, and facial pain) from 0 to 4. 0 = symptom-free/no symptom. mild symptom. moderate symptom. severe symptom. very severe symptom. This score will be assessed at the screening visit and follow-up visits at 4, 8 and 12 weeks. The total five-symptom score (T5SS) obtained with the sum of the individual symptoms (0-20).
Radiological evaluation [after 12 weeks from the start of treatment]
CT scan of the nose and paranasal sinuses will performed to all patients before and after the treatment and staged using the Lund-Mackay (LMK) scoring system where each sinus (maxillar, anterior ethmoidal, posterior eth-moidal, frontal, esphenoidal) is scored for opacification (0, no opacity; 1, partial opacity; 2, total opacity), and the ostiomeatal complex is scored 0 (no obstruction) or 2 (obstruction). The uni-lateral score goes from 0 to 12 whereas the bilateral score goes from 0 to 24.
Quality of life score [after 12 weeks from the start of treatment]
Subjects will complete validated questionnaire related to general quality of life lCSD (International Classification of Sinus Disease) before and after treatment. The ICSD records patients' symptoms of facial pain and pressure; headache ;nasal blockage Or congestion; nasal discharge; disturbance of smell; and Over all discomfort on a 0 to 10 ordinal scale.