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Montelukast and Loratadine in Children With Asthma

I

Innovation and Development of Health Strategies

Status and phase

Completed
Phase 3

Conditions

Asthma in Children

Treatments

Drug: Montelukast
Drug: Montelukast mixed with Loratadine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03372473
Montelukast2017

Details and patient eligibility

About

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.

Full 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

Enrollment

80 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups

Montelukast mixed with Loratadine
Experimental group
Description:
Montelukast 5mg mixed with Loratadine 5mg one dose a day
Treatment:
Drug: Montelukast mixed with Loratadine
Montelukast
Active Comparator group
Description:
Montelukast 5mg one dose per day
Treatment:
Drug: Montelukast

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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