Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis

Study Overview
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Brief Summary
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Comparison of Montelukast and Azelastine In treatment of Allergic Rhinitis Allergic intent is one of the most common diseases of the respiratory system that has a devastating effect on the quality of life. The importance of studying this disease can be seen from the high prevalence of this diseas. In addition to the high prevalence, due to the reducing effect of this disease on the economy and academic performance of patients, a great burden is imposed by this disease on the country's health care system.Also finding the best treatment of allergic can help to control of Asthma if exists concurrently. Inflammation of the nasal mucosa following the release of IgE can be shown as symptoms of runny nose, sneezing, nasal congestion.Many studies have been done in the field of allergic rhinitis to increase the cost-effectiveness of treatment of this complication. Among the treatments for this disease is the use of antihistamine nasal sprays such as Azelastine. Combination therapies such as combining Mometason furoate or fluticasone with Azelastine or Montelukast can also be mentioned. However, there is still a long way to go to find the best drug combination to reduce the economic and human costs to the global health system. Due to the high prevalence of allergic diseases such as allergic rhinitis, finding the best treatment or management of such diseases plays an important role in improving the quality of life and reducing the economic burden on society.

Official Title
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Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Montelukast
* Drug: Azelastine
* Drug: Budesonide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6-50years Moderate to severe allergic rhinitis Exclusion Criteria: Under any treatment Drug sensitivity

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azelastine and Nasal Budesonide<br>Spray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older | Drug: Azelastine<br>* Azelastine and nasal budesonide<br>Drug: Budesonide<br>* To all groups<br>|
| Active Comparator: Montelukast and Nasal budesonide<br>Montelukast 5mg 6-14years old and 10mg for older | Drug: Montelukast<br>* Montelukast and nasal budesonide<br>Drug: Budesonide<br>* To all groups<br>|
| Placebo Comparator: Nasal Budesonide and Placebo<br>Placebo once daily | Drug: Budesonide<br>* To all groups<br>Drug: Placebo<br>* Placebo and nasal budesonide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sino-Nasal Outcome Test scores (SNOT-22) | Change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment. The Sino-Nasal Outcome Test asks subjects to rate how bad their rhinosinusitis by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. | Baseline,month1,month3 |