Montelukast and Loratadine in Children With Asthma

Study Overview
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Brief Summary
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Randomized controlled trial in 80 children with mild to persistent moderate asthma, who were randomized to receive montelukast 5mg + loratadine 5mg vs. montelukast 5mg + placebo for loratadine to evaluate the efficacy in terms of improvement of symptoms. Secondary outcome was the days off without the use of rescue medication; reduction of levels of cysteinyl leukotrienes (Cys-LTS), nitric oxide (FeNO), intracellular adhesion molecule type 1 (ICAM-1) and interleukin 8 (IL-8) in condensed exhaled air; the improvement of day and night symptoms; the reduction in the frequency of night awakenings; the improvement in the quality of life; the percentage of related adverse events; the need to use systemic steroids; the number of visits to the emergency department secondary to the presence of an asthma attack; the number of hospitalizations secondary to asthma attacks; and the improvement in the percentage of FEV1 in relation to the predicted.

Detailed Description
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Asthma is a disease with increasing prevalence worldwide that produces significant deterioration of the quality of life in children and development of important complications and economic, social impact. Considering the concept of a common airway (coexistence of asthma and rhinitis), joint management initiatives with anti-asthmatics and anti-histamines have been published. The primary objective of this clinical trial is to evaluate the efficacy and safety of the use of montelukast + loratadine in children with asthma on the improvement of symptoms and secondarily to evaluate the impact on a) the days off without the use of rescue medication; b) reduction of levels of cysteinyl leukotrienes (Cys-LTS), nitric oxide (FeNO), intracellular adhesion molecule type 1 (ICAM-1) and interleukin 8 (IL-8) in condensed exhaled air; c) the improvement of day and night symptoms; d) the reduction in the frequency of night awakenings; e) the improvement in the quality of life; f) the percentage of related adverse events; g) the need to use systemic steroids; h) the number of visits to the emergency department secondary to the presence of an asthma attack; i) the number of hospitalizations secondary to asthma attacks; and j) the improvement in the percentage of FEV1 in relation to the predicted. We included 80 children from 6 to 12 years old, any sex, with mild to moderate persistent asthma, after signing an informed consent letter by parents or guardians or signing the child's consent (> 8 years). Children with chronic diseases associated with the disease of interest were excluded (heart disease, nephropathy, liver disease of any kind); with any other lung disease other than asthma; with a history of hypersensitivity to montelukast or loratadine or with a history of concomitant use of medications that interact significantly with montelukast or loratadine

Official Title
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Safety and Efficacy of Montelukast + Loratadine vs. Montelukast for the Control of Mild to Moderate Persistent Asthma in Children: Randomized Controlled Clinical Trial

Conditions
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Asthma in Children

Intervention / Treatment
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* Drug: Montelukast mixed with Loratadine
* Drug: Montelukast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 6 to 12 years old Any sex Persistent mild to moderate asthma Signature of informed consent letter by parents or guardians Letter of assent of the minor for children over 9 years of age Exclusion Criteria: Chronic pathologies associated with the disease of interest (heart disease, nephropathy, liver disease of any kind) Any other lung disease other than asthma History of hypersensitivity to montelukast or loratadine Concomitant use of medications that interact significantly with montelukast or loratadine

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized clinical crossover trial, in 80 children who were allocated to receive montelukast + loratadine vs montelukast in two different periods of 4 weeks each, with a 2 weeks of wash-out between periods of treatment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast mixed with Loratadine<br>Montelukast 5mg mixed with Loratadine 5mg one dose a day | Drug: Montelukast mixed with Loratadine<br>* Montelukast 5mg mixed with Loratadine 5mg, one dose per day<br>|
| Active Comparator: Montelukast<br>Montelukast 5mg one dose per day | Drug: Montelukast<br>* Montelukast 5mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free of symptoms | Number of days free of symptoms associated to asthma episodes | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free of rescue medication | Number of days free for use of rescue medications | 10 weeks | 
| Reduction of airway inflammatory profile | Measurement of inflamatory biomarkers in exhaled respiratory air | 10 weeks | 
| Reduction of awakenings | Frequency of nocturn awakenings | 10 weeks | 
| Quality of Life | Changes in PedsQL during the treatment | 10 weeks | 
| Emergency visits | Number of emergency visits secondary to asthma crisis | 10 weeks | 
| Adverse Events | Frequency of reported adverse events | 10 weeks |