Montelukast and Loratadine in Children With Asthma

• Status: Completed
• Trial end date: 2017-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovacion y Desarrollo de Estrategias en Salud
• Collaborators: Laboratorios Senosiain, S.A. de C.V.; National Institute of Pediatrics, Mexico
• Treatments: Loratadine; Montelukast

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