Role of Montelukast in Asthma and Allergic Rhinitis Patients

Study Overview
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Brief Summary
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To determine the effect of Montelukast in Asthma and Allergic rhinits patients

Detailed Description
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Montelukast is a potent and selective blocker of the CysLT1 receptor. Accordingly, a recent study has shown that Montelukast can improve symptoms of seasonal allergic rhinitis and asthma in patients with both diseases. For treatment of asthma, Montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form. Asthma and allergic rhinitis have been linked clinically for many years as one airway one diseases. Patients with allergic asthma and rhinitis are significantly more likely to experience asthma attacks compared to patients with asthma alone. Side effects most commonly reported above placebo included headache, otitis media, upper respiratory infection, and pharyngitis

Official Title
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Role of Montelukast in Asthma and Allergic Rhinitis Patients

Conditions
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Asthma and Allergic Rhinitis

Intervention / Treatment
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* Drug: Montelukast 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Signed Informed Consent Clinical diagnosis of Asthma and Allergic Rhinitis Exclusion Criteria: Previous adverse reaction to Montelukast History of hyper-eosinophilic disorder other than atopic disease Female subjects who are pregnant, breast-feeding Any significant and active pulmonary pathology other than asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast 10 mg<br>Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis. | Drug: Montelukast 10mg<br>* Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis. Montelukast should be taken once daily in the evening<br>* Other names: Aireez;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment | To determine the efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment [Designated as safety issue: No] [Time Frame: 0 days to 4 weeks] | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment | To determine the efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment [Designated as safety issue: No] [Time Frame: 0 days to 4 weeks] | 4 weeks | 
| Effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment | To determine the effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment [Designated as safety issue: No] [Time Frame: 0 days to 4 weeks] | 4 weeks | 
| Proportion of participants experiencing an adverse event (AE) | Proportion of participants experiencing an adverse event (AE) [Designated as safety issue: Yes] [Time Frame: 0 days to 4 weeks] | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MAAP, Asthma, Allergic rhinits