Role of Montelukast in Asthma and Allergic Rhinitis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2019-06-30

Brief Summary

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To determine the effect of Montelukast in Asthma and Allergic rhinits patients

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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

Conditions

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Asthma and Allergic Rhinitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor.Montelukast should be taken once daily in the evening

Study Groups

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Montelukast 10 mg

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.

Group Type EXPERIMENTAL

Montelukast 10mg

Intervention Type DRUG

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

Interventions

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Montelukast 10mg

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

Intervention Type DRUG

Other Intervention Names

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Aireez

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No