Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers

May 14, 2022 updated by: Hadeer Ashraf Farouk, Assiut University
To examine the efficacy of Montelukast as an adjunct to INCS in patients with allergic rhinitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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].

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Montelukast
Montelukast, 10 mg, oraly Local corticosteriod nasal spary
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
Other Names:
  • Fluticasone Furoate nasal spary
NO_INTERVENTION: No drug
No drug taking , only local corticosteriod nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal symptoms
Time Frame: 3 monthes

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
laboratory findings
Time Frame: 3 months
Evaluation of inflammatory markers levels (TNF-α, 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
Quality of life symptoms
Time Frame: 3 monthes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2022

Primary Completion (ANTICIPATED)

October 1, 2024

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

May 8, 2022

First Submitted That Met QC Criteria

May 14, 2022

First Posted (ACTUAL)

May 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 14, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Montelukast on A.R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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