Role of Montelukast in Asthma and Allergic Rhinitis Patients

Clinision600 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Asthma and Allergic Rhinitis

Interventions

Montelukast 10mgDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr. Faisal Faiyaz Zuberi

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

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 \[Designated as safety issue: No\] \[Time Frame: 0 days to 4 weeks\]

Time frame: 4 weeks

Secondary Outcomes

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 \[Designated as safety issue: No\] \[Time Frame: 0 days to 4 weeks\]

Time frame: 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 \[Designated as safety issue: No\] \[Time Frame: 0 days to 4 weeks\]

Time frame: 4 weeks

Proportion of participants experiencing an adverse event (AE)

Proportion of participants experiencing an adverse event (AE) \[Designated as safety issue: Yes\] \[Time Frame: 0 days to 4 weeks\]

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.