Montelukast and Loratadine in Children With Asthma
Status:
Completed
Trial end date:
2017-06-30
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Innovacion y Desarrollo de Estrategias en Salud
Collaborators:
Laboratorios Senosiain, S.A. de C.V. National Institute of Pediatrics, Mexico