Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers

NCT05381207 | Unknown Early Phase 1

• 1 other identifier: Montelukast on A.R
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Allergic Rhinitis

Keywords

Montelukast; Allergic Rhinitis

Outcome Measures

Primary Outcomes (3)

• 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

• laboratory findings

  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

  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

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

Montelukast, 10 mg, oraly Local corticosteriod nasal spary

Drug: Montelukast Oral Tablet

No drug

NO INTERVENTION

No drug taking , only local corticosteriod nasal spray

Interventions

Montelukast Oral Tablet 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

Also known as: Fluticasone Furoate nasal spary

Montelukast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

montelukast

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Hadeer Ashraf Farouk, Baclora

CONTACT

0201142550880; hadeer011476@med.au.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 19, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 19, 2022

Record last verified: 2022-05