Status:

COMPLETED

Montelukast and Loratadine in Children With Asthma

Lead Sponsor:

Innovacion y Desarrollo de Estrategias en Salud

Collaborating Sponsors:

National Institute of Pediatrics, Mexico

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

Conditions:

Asthma in Children

Eligibility:

All Genders

6-12 years

Phase:

PHASE3

Brief 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 eval...

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 impa...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 10 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2017

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT03372473

Start Date

January 10 2016

End Date

June 30 2017

Last Update

December 13 2017

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