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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Change in Total Nasal Symptom Score (TNSS) [Срок оценки: Baseline to 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Liaquat National Hospital and Medical College — Karachi

Идентификаторы

NCT: NCT07532993 · 1309-2025-LNH-ERC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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