Montelukast and Loratadine in Children With Asthma

Asthma in Children Clinical Trial

Official title:

Safety and Efficacy of Montelukast + Loratadine vs. Montelukast for the Control of Mild to Moderate Persistent Asthma in Children: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372473
• Other study ID #: Montelukast2017
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2017
• Last updated: December 12, 2017
• Start date: January 10, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: December 2017
• Source: Innovacion y Desarrollo de Estrategias en Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2017
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Drug:
• Montelukast mixed with Loratadine
Montelukast 5mg mixed with Loratadine 5mg, one dose per day
• Montelukast
Montelukast 5mg

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Innovacion y Desarrollo de Estrategias en Salud	Laboratorios Senosiain, S.A. de C.V., National Institute of Pediatrics, Mexico

References & 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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Re — View Citation

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. Errat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free of symptoms	Number of days free of symptoms associated to asthma episodes	10 weeks
Secondary	Free of rescue medication	Number of days free for use of rescue medications	10 weeks
Secondary	Reduction of airway inflammatory profile	Measurement of inflamatory biomarkers in exhaled respiratory air	10 weeks
Secondary	Reduction of awakenings	Frequency of nocturn awakenings	10 weeks
Secondary	Quality of Life	Changes in PedsQL during the treatment	10 weeks
Secondary	Emergency visits	Number of emergency visits secondary to asthma crisis	10 weeks
Secondary	Adverse Events	Frequency of reported adverse events	10 weeks