montelukast and loratadine in children with asthma

Conditions: Asthma in Children

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.

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

Eligibility criteria:
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