Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers

NCT ID: NCT05381207

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2024-10-31

Brief Summary

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

Detailed 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].

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Montelukast

Montelukast, 10 mg, oraly Local corticosteriod nasal spary

Group Type: ACTIVE_COMPARATOR

Montelukast Oral Tablet

Intervention Type: DRUG

Subjects in group A (study) 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 months. Subjects group B (control) will receive only topical steroids in an identical regimen

No drug

No drug taking , only local corticosteriod nasal spray

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Montelukast Oral Tablet

Subjects in group A (study) 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 months. Subjects group B (control) will receive only topical steroids in an identical regimen

Intervention Type: DRUG

Other Intervention Names

Fluticasone Furoate nasal spary

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hadeer Ashraf Farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hadeer Ashraf Farouk, Baclora

Role: CONTACT

hadeer011476@med.au.edu.eg

0201142550880

Other Identifiers

Montelukast on A.R

Identifier Type: -

Identifier Source: org_study_id