Montelukast and Loratadine in Children With Asthma

• ClinicalTrials.gov Identifier: NCT03372473
• Recruitment Status: Completed
• First Posted: December 13, 2017
• Last Update Posted: December 13, 2017
• Sponsor: Innovacion y Desarrollo de Estrategias en Salud
• Collaborators: National Institute of Pediatrics, Mexico; Laboratorios Senosiain, S.A. de C.V.
• Information provided by (Responsible Party): Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma in Children	Drug: Montelukast mixed with Loratadine; Drug: Montelukast	Phase 3

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 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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 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
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 10, 2016
• Actual Primary Completion Date: February 1, 2016
• Actual Study Completion Date: June 30, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Montelukast mixed with Loratadine; Montelukast 5mg mixed with Loratadine 5mg one dose a day	Drug: Montelukast mixed with Loratadine; Montelukast 5mg mixed with Loratadine 5mg, one dose per day
Active Comparator: Montelukast; Montelukast 5mg one dose per day	Drug: Montelukast; Montelukast 5mg

Outcome Measures

Primary Outcome Measures :

1. Free of symptoms [ Time Frame: 10 weeks ]
   Number of days free of symptoms associated to asthma episodes

Secondary Outcome Measures :

1. Free of rescue medication [ Time Frame: 10 weeks ]
   Number of days free for use of rescue medications
2. Reduction of airway inflammatory profile [ Time Frame: 10 weeks ]
   Measurement of inflamatory biomarkers in exhaled respiratory air
3. Reduction of awakenings [ Time Frame: 10 weeks ]
   Frequency of nocturn awakenings
4. Quality of Life [ Time Frame: 10 weeks ]
   Changes in PedsQL during the treatment
5. Emergency visits [ Time Frame: 10 weeks ]
   Number of emergency visits secondary to asthma crisis
6. Adverse Events [ Time Frame: 10 weeks ]
   Frequency of reported adverse events

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Innovacion y Desarrollo de Estrategias en Salud

National Institute of Pediatrics, Mexico

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

Investigators

• Principal Investigator: Pedro Gutierrez Castrellon, MD; Hospital General Dr. Manuel Gea Gonzalez

More Information

Publications of Results:

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.

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.

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.

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. Erratum in: J Allergy Clin Immunol. 2004 Apr;113(4):676.

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. Review.

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.

• Responsible Party: Pedro Gutierrez Castrellon, Head of Translational Research Center on Mother-Child Health, Innovacion y Desarrollo de Estrategias en Salud
• ClinicalTrials.gov Identifier: NCT03372473
• Other Study ID Numbers: Montelukast2017
• First Posted: December 13, 2017
• Last Update Posted: December 13, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Loratadine; Montelukast; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action; Antipruritics; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents