Role of Montelukast in Asthma and Allergic Rhinitis Patients

Phase 4

Completed

• Conditions: Asthma and Allergic Rhinitis
• Interventions: Drug: Montelukast 10mg

• Registration Number: NCT03380975
• Lead Sponsor: Clinision

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-21
• Study Start: 2018-08-28
• Primary Completion: 2019-03-25
• Study Completion: 2019-06-30
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Montelukast 10 mg	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dr. Faisal Faiyaz Zuberi; 🇵🇰 Karachi, Sindh, Pakistan