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

NCT05143502 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: Montelukast in nasal polyps
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Montelukast; Chronic Rhinosinusitis With Nasal Polyps

Keywords

Montelukast; Chronic Rhinosinusitis with Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• 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. 1. small nasal polyps not reaching the inferior border of the middle turbinate. 2. nasal polyps reaching beyond the inferior border of the middle turbinate. 3. large nasal polyps reaching the lower edge of the inferior turbinate 4. very large nasal polyps in contact with the floor of the nasal cavity.

  after 12 weeks from the start of treatment

Secondary Outcomes (3)

• Nasal symptoms.

  after 12 weeks from the start of treatment

• Radiological evaluation

  after 12 weeks from the start of treatment

• Quality of life score

  after 12 weeks from the start of treatment

Study Arms (2)

Montelukast Group

EXPERIMENTAL

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; Drug: Prednisolone; Drug: Fluticasone Furoate

Control Group

ACTIVE COMPARATOR

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

Drug: Prednisolone; Drug: Fluticasone Furoate

Interventions

Montelukast DRUG

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

Montelukast Group

Prednisolone DRUG

Oral Prednisolone 40 mg/day for two weeks.

Control Group; Montelukast Group

Fluticasone Furoate DRUG

fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily

Control Group; Montelukast Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1- Adult patients (aged 18 years and over)
• Bilateral denovo nasal polyps confirmed by nasal endoscopy and CT scan.

You may not qualify if:

• \- 1- CRS patients without nasal polyposis.
• Patient with unilateral nasal polyp.
• Revision cases (history of previous surgical treatment).
• Patient with fungal rhinosinusitis..
• Pregnancy and lactation.
• Malignancies.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (10)

• 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.

  PMID: 22469599 BACKGROUND

• 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.

  PMID: 27042129 BACKGROUND

• 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.

  PMID: 12903683 BACKGROUND

• 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.

  PMID: 27544740 BACKGROUND

• 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.

  PMID: 18167126 BACKGROUND

• 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.

  PMID: 18722209 BACKGROUND

• 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.

  PMID: 22410935 BACKGROUND

• 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.

  PMID: 30810118 BACKGROUND

• 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.

  PMID: 12532084 BACKGROUND

• 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.

  PMID: 22830292 BACKGROUND

MeSH Terms

Interventions

montelukast; Prednisolone; fluticasone furoate

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residant

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: December 3, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

EG (1)