NCT07532993

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Liaquat National Hospital & Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-02-01
• Completion: 2027-05-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Pakistan