Comparison of Antihistamine and Antileukotriene Add-On Therapy to Intranasal Corticosteroid in Allergic Rhinitis

Comparison of Intranasal Corticosteroid Plus Oral Antihistamine Versus Intranasal Corticosteroid Plus Oral Antileukotriene in Patients With Allergic Rhinitis

Allergic rhinitis is a very common condition that can cause symptoms such as sneezing, a runny nose, nasal blockage, and itching in the nose. These symptoms can interfere with sleep, daily activities, and overall quality of life. Although several medicines are available to treat allergic rhinitis, it is not always clear which combination of treatments works best for patients in everyday clinical practice.

The purpose of this study is to compare two commonly used treatment combinations for allergic rhinitis in adults. One group of participants will receive an intranasal corticosteroid along with an oral antihistamine. The other group will receive an intranasal corticosteroid along with an oral antileukotriene. Both treatment approaches aim to reduce inflammation and improve symptoms, but they act through different pathways in the body.

This study is designed as a randomized controlled trial. Participants who meet the eligibility criteria will be assigned by chance to one of the two treatment groups. This method helps ensure that the comparison between treatments is fair and unbiased.

The main goal of the study is to find out whether one treatment combination provides better relief of nasal symptoms than the other, or if both treatments are equally effective. To assess this, participants' symptoms will be recorded using a structured symptom scoring system at the start of the study and during follow-up visits.

Participants will be evaluated at baseline and at scheduled follow-up visits. Changes in their symptoms over time will be carefully monitored and compared between the two groups. The results of this study may help doctors choose the most effective treatment approach for adults with allergic rhinitis and support better evidence-based care.

This study has been reviewed and approved by the institutional ethical review committee. Participation in the study is voluntary, and informed consent will be obtained from all participants before enrollment.

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Rhinitis (AR)
• Intervention / Treatment: Drug: Mometasone Furoate Nasal spray; Drug: Loratadine 10 Mg; Drug: Montelukast 10 mg

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Raja Muhammad Suleman Qadir, MBBS; Phone Number: +923055992616; Email: isuleman52435@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75400
      • Liaquat National Hospital and Medical College
      • Contact: Raja Muhammad Suleman Qadir, MBBS; Phone Number: +923055992616; Email: isuleman52435@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18-60 years with a clinical diagnosis of allergic rhinitis.
• Patients with moderate to severe symptoms (nasal obstruction, rhinorrhea, sneezing, itching).
• Patients willing to participate and provide informed consent.
• Patients not using antihistamines, antileukotrienes, or corticosteroids for at least 2 weeks prior to enrollment.

Exclusion Criteria:

• Patients with bronchial asthma, chronic rhinosinusitis, nasal polyps, or significant nasal pathology.
• Known hypersensitivity to study medications.
• Pregnant or lactating women.
• Use of systemic corticosteroids or immunotherapy within the past 4 weeks.
• Active nasal or sinus infection.
• Patients with significant systemic illness or unable to comply with follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intranasal Corticosteroid + Oral Antihistamine; Participants in this group will receive an intranasal corticosteroid in combination with an oral antihistamine for the treatment of allergic rhinitis. The treatment aims to reduce nasal inflammation and control symptoms such as sneezing, nasal discharge, itching, and nasal obstruction.	Drug: Mometasone Furoate Nasal spray; Mometasone furoate nasal spray (50 micrograms per spray) will be administered as two sprays per nostril once daily as an intranasal corticosteroid to reduce nasal mucosal inflammation and improve symptoms of allergic rhinitis.; Other Names: Nasomet; Drug: Loratadine 10 Mg; Loratadine 10 mg will be administered orally once daily as an antihistamine to control symptoms of allergic rhinitis, including sneezing, itching, and rhinorrhea.; Other Names: Softin
Active Comparator: Intranasal Corticosteroid + Oral Antileukotriene; Participants in this group will receive an intranasal corticosteroid in combination with an oral antileukotriene for the treatment of allergic rhinitis. This treatment approach targets inflammatory pathways to improve nasal symptoms and overall disease control.	Drug: Mometasone Furoate Nasal spray; Mometasone furoate nasal spray (50 micrograms per spray) will be administered as two sprays per nostril once daily as an intranasal corticosteroid to reduce nasal mucosal inflammation and improve symptoms of allergic rhinitis.; Other Names: Nasomet; Drug: Montelukast 10 mg; Montelukast 10 mg will be administered orally once daily as an antileukotriene agent to reduce inflammation and improve symptoms in patients with allergic rhinitis.; Other Names: Myteka

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Nasal Symptom Score (TNSS)	Total Nasal Symptom Score (TNSS) will be used to assess symptom severity in patients with allergic rhinitis. TNSS includes four symptoms: nasal obstruction, rhinorrhea, sneezing, and nasal itching, each scored from 0 (no symptoms) to 3 (severe symptoms), with a total score ranging from 0 to 12. The primary outcome will be the change in TNSS from baseline to 4 weeks after initiation of treatment.	Baseline to 4 weeks

Collaborators and Investigators

• Sponsor: Liaquat National Hospital & Medical College
• Investigators: Study Director: Ahmad Nawaz Ahmad, MBBS, MCPS, FCPS, MHPE, Liaquat National Hospital and Medical College; Principal Investigator: Raja Muhammad Suleman Qadir, MBBS, Liaquat National Hospital and Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Piperidines; Dibenzocycloheptenes; Benzocycloheptenes; Cyproheptadine; Loratadine; montelukast
• Other Study ID Numbers: 1309-2025-LNH-ERC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to institutional policies and to protect participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No