Montelukast and Loratadine in Children With Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

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
    

Intervention name(s): Montelukast mixed with Loratadine; Montelukast
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 5mg mixed with Loratadine 5mg, one dose per day; Montelukast 5mg
Intervention MeSH terms: Loratadine; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment