Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers

Allergic Rhinitis Clinical Trial

Official title:

Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05381207
• Other study ID #: Montelukast on A.R
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: October 2022
• Est. completion date: October 2024

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: Hadeer Ashraf Farouk, Baclora
• Phone: 0201142550880
• Email: hadeer011476[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal symptoms	Participants will be asked to score five Sino-nasal symptoms (nasal congestion/obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of smell, and facial pain) from 0 to 4.; This score will be assessed at the screening and follow-up visits at 12 weeks. The total five-symptom score (T5SS) was obtained with the sum of the individual symptoms (0-20).	3 monthes
Primary	laboratory findings	Evaluation of inflammatory markers levels (TNF-a, IL-6, IL-12) in inpatient blood At 0 point premedication (pre-medication) At 1 point post medication after 12 weeks (3 months)	3 months
Primary	Quality of life symptoms	Subjects will complete a validated questionnaire related to the general quality of life in patients with allergic rhinitis; this questionnaire records patients' symptoms The patients receive a rhino-conjunctivitis quality of life questionnaire. This questionnaire records domains like patient activities, sleep, ......and emotional problems on an 0-x ordinal scale.	3 monthes