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Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers

A

Assiut University

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Allergic Rhinitis

Treatments

Drug: Montelukast Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05381207
Montelukast on A.R

Details and patient eligibility

About

To examine the efficacy of Montelukast as an adjunct to INCS in patients with allergic rhinitis.

Full description

Allergic rhinitis (AR) is a non-infectious inflammatory disease occurring in nasal mucosa with nasal itching, nasal congestion, rhinorrhea, and sneezing as its main clinical symptoms, which are induced by immunoglobulin E-mediated chemical mediators with the participation of various immunologically competent cells and cytokines after allergen exposure. (1) According to statistics, AR affects 10% to 25% of the global population. (2).

AR could be investigated by skin prick test, A blood test to check for the immunoglobulin E (IgE) antibody, and Total blood eosinophil count. (3) Current guidelines suggest that Intranasal corticosteroids should be used as the first line of treatment (4).

Surgical care may be indicated for comorbid or complicating conditions such as chronic sinusitis and nasal polyps. (5) Many studies have proven that the abnormality of inflammatory factors such as(TNF-α, IL-6, and IL-12)are closely related to the pathogenesis of AR. (6)these inflammatory factors participate in the regulation of immune response through media leucocyte chemotaxis and activate, so elevate of levels of these 3 factors can reflect the aggravation of inflammatory markers in the patient with AR. (7) Montelukast is belonging to the leukotriene receptor antagonists with the effect of inhibiting the expression of cysteinyl leukotriene involved in the pathogen of AR. Thus, the inhibition of the inflammatory marker can effectively reduce airway inflammatory response, nasal mucosal edema, and inflammatory exudation etiologically [8].

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult patients (aged 18 years and over) with AR. Clinical diagnosis of Allergic Rhinits Must be able to swallow tablets

Exclusion criteria

Bronchial Asthma patients. Patients already on Antihistamine combined treatment Patients who are allergic to this medication Advanced liver or kidney diseases.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Montelukast
Active Comparator group
Description:
Montelukast, 10 mg, oraly Local corticosteriod nasal spary
Treatment:
Drug: Montelukast Oral Tablet
No drug
No Intervention group
Description:
No drug taking , only local corticosteriod nasal spray

Trial contacts and locations

0

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Central trial contact

Hadeer Ashraf Farouk, Baclora

Data sourced from clinicaltrials.gov

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