Montelukast and Loratadine in Children With Asthma
- Conditions
- Asthma in Children
- Interventions
- Registration Number
- NCT03372473
- Lead Sponsor
- Innovacion y Desarrollo de Estrategias en Salud
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Montelukast mixed with Loratadine Montelukast mixed with Loratadine Montelukast 5mg mixed with Loratadine 5mg one dose a day Montelukast Montelukast Montelukast 5mg one dose per day
- Primary Outcome Measures
Name Time Method Free of symptoms 10 weeks Number of days free of symptoms associated to asthma episodes
- Secondary Outcome Measures
Name Time Method Emergency visits 10 weeks Number of emergency visits secondary to asthma crisis
Adverse Events 10 weeks Frequency of reported adverse events
Free of rescue medication 10 weeks Number of days free for use of rescue medications
Reduction of airway inflammatory profile 10 weeks Measurement of inflamatory biomarkers in exhaled respiratory air
Reduction of awakenings 10 weeks Frequency of nocturn awakenings
Quality of Life 10 weeks Changes in PedsQL during the treatment