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

NCT07532993 | Not Yet Recruiting Phase 4

• 1 other identifier: 1309-2025-LNH-ERC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis (AR)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intranasal Corticosteroid + Oral Antihistamine

ACTIVE COMPARATOR

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; Drug: Loratadine 10 Mg

Intranasal Corticosteroid + Oral Antileukotriene

ACTIVE COMPARATOR

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; Drug: Montelukast 10 mg

Interventions

Mometasone Furoate Nasal spray DRUG

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.

Also known as: Nasomet

Intranasal Corticosteroid + Oral Antihistamine; Intranasal Corticosteroid + Oral Antileukotriene

Loratadine 10 Mg DRUG

Loratadine 10 mg will be administered orally once daily as an antihistamine to control symptoms of allergic rhinitis, including sneezing, itching, and rhinorrhea.

Also known as: Softin

Intranasal Corticosteroid + Oral Antihistamine

Montelukast 10 mg DRUG

Montelukast 10 mg will be administered orally once daily as an antileukotriene agent to reduce inflammation and improve symptoms in patients with allergic rhinitis.

Also known as: Myteka

Intranasal Corticosteroid + Oral Antileukotriene

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

Study Sites (1)

Liaquat National Hospital and Medical College

Karachi, Sindh, 75400, Pakistan

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Loratadine; montelukast

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Ahmad Nawaz Ahmad, MBBS, MCPS, FCPS, MHPE

  Liaquat National Hospital and Medical College

  STUDY DIRECTOR

• Raja Muhammad Suleman Qadir, MBBS

  Liaquat National Hospital and Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raja Muhammad Suleman Qadir, MBBS

CONTACT

+923055992616; isuleman52435@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Raja Muhammad Suleman Qadir

Model Details: Participants will be randomly assigned in a parallel manner to one of two treatment groups. One group will receive an intranasal corticosteroid in combination with an oral antihistamine, while the other group will receive an intranasal corticosteroid in combination with an oral antileukotriene. Outcomes will be assessed and compared between the two groups over the study period.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)