Title
Montelukast and Loratadine in Children With Asthma
Safety and Efficacy of Montelukast + Loratadine vs. Montelukast for the Control of Mild to Moderate Persistent Asthma in Children: Randomized Controlled Clinical Trial
Phase
Phase 3Lead Sponsor
Hospital General Dr. Manuel Gea GonzalezStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Asthma in ChildrenIntervention/Treatment
montelukast loratadine ...Study Participants
80Randomized 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.
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
Montelukast 5mg mixed with Loratadine 5mg, one dose per day
Montelukast 5mg
Montelukast 5mg mixed with Loratadine 5mg one dose a day
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
