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Montelukast and Loratadine in Children With Asthma

NCT ID: NCT03372473

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-10

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized clinical crossover trial, in 80 children who were allocated to receive montelukast + loratadine vs montelukast in two different periods of 4 weeks each, with a 2 weeks of wash-out between periods of treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Children allocated on different arms will receive montelukast + loratadine vs. montelukast + placebo. Both product are identical in appearence and flavor

Study Groups

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Montelukast mixed with Loratadine

Montelukast 5mg mixed with Loratadine 5mg one dose a day

Group Type EXPERIMENTAL

Montelukast mixed with Loratadine

Intervention Type DRUG

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

Montelukast

Montelukast 5mg one dose per day

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

Montelukast 5mg

Interventions

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Montelukast mixed with Loratadine

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

Intervention Type DRUG

Montelukast

Montelukast 5mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Pediatrics, Mexico

OTHER_GOV

Sponsor Role collaborator

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

INDUSTRY

Sponsor Role collaborator

Innovacion y Desarrollo de Estrategias en Salud

OTHER

Sponsor Role lead

Responsible Party

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Pedro Gutierrez Castrellon

Head of Translational Research Center on Mother-Child Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pedro Gutierrez Castrellon, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Dr. Manuel Gea Gonzalez

References

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American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.

Reference Type RESULT
PMID: 15817806 (View on PubMed)

Carpagnano GE, Spanevello A, Sabato R, Depalo A, Palladino GP, Bergantino L, Foschino Barbaro MP. Systemic and airway inflammation in sleep apnea and obesity: the role of ICAM-1 and IL-8. Transl Res. 2010 Jan;155(1):35-43. doi: 10.1016/j.trsl.2009.09.004.

Reference Type RESULT
PMID: 20004360 (View on PubMed)

Carraro S, Corradi M, Zanconato S, Alinovi R, Pasquale MF, Zacchello F, Baraldi E. Exhaled breath condensate cysteinyl leukotrienes are increased in children with exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2005 Apr;115(4):764-70. doi: 10.1016/j.jaci.2004.10.043.

Reference Type RESULT
PMID: 15805996 (View on PubMed)

Zanconato S, Carraro S, Corradi M, Alinovi R, Pasquale MF, Piacentini G, Zacchello F, Baraldi E. Leukotrienes and 8-isoprostane in exhaled breath condensate of children with stable and unstable asthma. J Allergy Clin Immunol. 2004 Feb;113(2):257-63. doi: 10.1016/j.jaci.2003.10.046.

Reference Type RESULT
PMID: 14767439 (View on PubMed)

Massingham K, Fox S, Smaldone A. Asthma therapy in pediatric patients: a systematic review of treatment with montelukast versus inhaled corticosteroids. J Pediatr Health Care. 2014 Jan-Feb;28(1):51-62. doi: 10.1016/j.pedhc.2012.11.005. Epub 2013 Jan 9.

Reference Type RESULT
PMID: 23312367 (View on PubMed)

Corren J, Manning BE, Thompson SF, Hennessy S, Strom BL. Rhinitis therapy and the prevention of hospital care for asthma: a case-control study. J Allergy Clin Immunol. 2004 Mar;113(3):415-9. doi: 10.1016/j.jaci.2003.11.034.

Reference Type RESULT
PMID: 15007339 (View on PubMed)

Other Identifiers

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Montelukast2017

Identifier Type: -

Identifier Source: org_study_id