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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raja Muhammad Suleman Qadir, MBBS | Contact | +923055992616 | isuleman52435@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaquat National Hospital and Medical College | Karachi | Sindh | 75400 | Pakistan |
Individual participant data (IPD) will not be shared due to institutional policies and to protect participant confidentiality.
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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.
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| 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. |
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| 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. |
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|
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017336 | Loratadine |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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