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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps; Montelukast
• Intervention / Treatment: Drug: Montelukast; Drug: Prednisolone; Drug: Fluticasone Furoate

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change at nasal polyp size	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.	after 12 weeks from the start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal symptoms.	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).	after 12 weeks from the start of treatment
Radiological evaluation	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.	after 12 weeks from the start of treatment
Quality of life score	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.	after 12 weeks from the start of treatment

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
• Langdon C, Mullol J. Nasal polyps in patients with asthma: prevalence, impact, and management challenges. J Asthma Allergy. 2016 Mar 14;9:45-53. doi: 10.2147/JAA.S86251. eCollection 2016.
• Johansson L, Akerlund A, Holmberg K, Melen I, Bende M. Prevalence of nasal polyps in adults: the Skovde population-based study. Ann Otol Rhinol Laryngol. 2003 Jul;112(7):625-9. doi: 10.1177/000348940311200709.
• Wang X, Zhang N, Bo M, Holtappels G, Zheng M, Lou H, Wang H, Zhang L, Bachert C. Diversity of TH cytokine profiles in patients with chronic rhinosinusitis: A multicenter study in Europe, Asia, and Oceania. J Allergy Clin Immunol. 2016 Nov;138(5):1344-1353. doi: 10.1016/j.jaci.2016.05.041. Epub 2016 Jul 15.
• Scadding GK, Durham SR, Mirakian R, Jones NS, Drake-Lee AB, Ryan D, Dixon TA, Huber PA, Nasser SM; British Society for Allergy and Clinical Immunology. BSACI guidelines for the management of rhinosinusitis and nasal polyposis. Clin Exp Allergy. 2008 Feb;38(2):260-75. doi: 10.1111/j.1365-2222.2007.02889.x. Epub 2007 Dec 20.
• Joe SA, Thambi R, Huang J. A systematic review of the use of intranasal steroids in the treatment of chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2008 Sep;139(3):340-7. doi: 10.1016/j.otohns.2008.05.628.
• Rudmik L, Schlosser RJ, Smith TL, Soler ZM. Impact of topical nasal steroid therapy on symptoms of nasal polyposis: a meta-analysis. Laryngoscope. 2012 Jul;122(7):1431-7. doi: 10.1002/lary.23259. Epub 2012 Mar 12.
• Fokkens W, Desrosiers M, Harvey R, Hopkins C, Mullol J, Philpott C, Alobid I, Anselmo-Lima WT, Bachert C, Baroody F, Bernal-Sprekelsen M, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Douglas R, Gevaert P, Hafner A, Hellings P, Joos G, Kalogjera L, Kern R, Knill A, Kocks J, Landis BN, Limpens J, Lebeer S, Lourenco O, Matricardi PM, Meco C, O Mahony L, Reitsma S, Ryan D, Schlosser R, Senior B, Smith T, Teeling T, Tomazic PV, Toppila-Salmi S, Wang DY, Wang D, Zhang L, Lund V. EPOS2020: development strategy and goals for the latest European Position Paper on Rhinosinusitis. Rhinology. 2019 Jun 1;57(3):162-168. doi: 10.4193/Rhin19.080.
• Holgate ST, Peters-Golden M, Panettieri RA, Henderson WR Jr. Roles of cysteinyl leukotrienes in airway inflammation, smooth muscle function, and remodeling. J Allergy Clin Immunol. 2003 Jan;111(1 Suppl):S18-34; discussion S34-6. doi: 10.1067/mai.2003.25.
• Cao Y, Wang J, Bunjhoo H, Xie M, Xu Y, Fang H. Comparison of leukotriene receptor antagonists in addition to inhaled corticosteroid and inhaled corticosteroid alone in the treatment of adolescents and adults with bronchial asthma: a meta-analysis. Asian Pac J Allergy Immunol. 2012 Jun;30(2):130-8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: November 20, 2021
• First Posted (ACTUAL): December 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Montelukast; Chronic Rhinosinusitis with Nasal Polyps
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Nasal Polyps; Polyps; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Anti-Allergic Agents; Prednisolone; Montelukast; Fluticasone; Xhance
• Other Study ID Numbers: Montelukast in nasal polyps

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes