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Montelukast and Loratadine in Children With Asthma

NCT03372473 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-12-13

No results posted yet for this study

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.

Conditions

  • Asthma in Children

Interventions

DRUG

Montelukast mixed with Loratadine

Montelukast 5mg mixed with Loratadine 5mg, one dose per day

DRUG

Montelukast

Montelukast 5mg

Sponsors & Collaborators

  • National Institute of Pediatrics, Mexico

    collaborator OTHER_GOV

  • Laboratorios Senosiain, S.A. de C.V.

    collaborator INDUSTRY

  • Innovacion y Desarrollo de Estrategias en Salud

    lead OTHER

Principal Investigators

  • Pedro Gutierrez Castrellon, MD · Hospital General Dr. Manuel Gea Gonzalez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-10
Primary Completion
2016-02-01
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03372473 on ClinicalTrials.gov