Comparison of Intranasal Corticosteroid Plus Oral Antihistamine Versus Intranasal Corticosteroid Plus Oral Antileukotriene in Patients With Allergic Rhinitis
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change in Total Nasal Symptom Score (TNSS)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Loratadine 10 Mg (Drug)
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.
Intervention: Mometasone Furoate Nasal spray (Drug)
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.
Intervention: Montelukast 10 mg (Drug)
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.
Intervention: Mometasone Furoate Nasal spray (Drug)
Outcomes
Primary Outcomes
Change in Total Nasal Symptom Score (TNSS)
Time Frame: Baseline to 4 weeks
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Raja Muhammad Suleman Qadir
Dr. Raja Muhammad Suleman Qadir
Liaquat National Hospital & Medical College