Montelukast and Loratadine in Children With Asthma

NCT03372473 | Completed Phase 3

• 1 other identifier: Montelukast2017
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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 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

Outcome Measures

Primary Outcomes (1)

• Free of symptoms

  Number of days free of symptoms associated to asthma episodes

  10 weeks

Secondary Outcomes (6)

• Free of rescue medication

  10 weeks

• Reduction of airway inflammatory profile

  10 weeks

• Reduction of awakenings

  10 weeks

• Quality of Life

  10 weeks

• Emergency visits

  10 weeks

Study Arms (2)

Montelukast mixed with Loratadine

EXPERIMENTAL

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

Drug: Montelukast mixed with Loratadine

Montelukast

ACTIVE COMPARATOR

Montelukast 5mg one dose per day

Drug: Montelukast

Interventions

Montelukast mixed with Loratadine DRUG

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

Montelukast mixed with Loratadine

Montelukast DRUG

Montelukast 5mg

Montelukast

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovacion y Desarrollo de Estrategias en Salud: lead
• National Institute of Pediatrics, Mexico: collaborator
• Laboratorios Senosiain, S.A. de C.V.: collaborator

Related Publications (6)

• 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.

  PMID: 15817806 RESULT

• 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.

  PMID: 20004360 RESULT

• 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.

  PMID: 15805996 RESULT

• 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.

  PMID: 14767439 RESULT

• 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.

  PMID: 23312367 RESULT

• 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.

  PMID: 15007339 RESULT

MeSH Terms

Interventions

Loratadine; montelukast

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Pedro Gutierrez Castrellon, MD

  Hospital General Dr. Manuel Gea Gonzalez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Translational Research Center on Mother-Child Health

Model Details: 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

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: January 10, 2016
• Primary Completion: February 1, 2016
• Study Completion: June 30, 2017
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share