Montelukast added to budesonide in children with persistent asthma: A randomized, double-blind, crossover study

Simons, F. Estelle R.; Villa, José Ramón; Lee, Bee W.; Teper, Alejandro; Lyttle, Brian; Aristizábal, Gustavo; Laessig, Wolfgang; Schuster, Antje; Pérez‐Frías, Javier; Şekerel, Bülent Enis; Menten, Joris; Leff, Jonathan A.

doi:10.1067/mpd.2001.112899

Cited by 162 publications

(90 citation statements)

References 22 publications

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“…CysLTs cause bronchoconstriction, which contributes to early-and late-phase responses to the inhaled allergen challenge (13) and induce airway remodeling (14). Clinical reports and experimental studies have demonstrated that the LT antagonist montelukast may reduce asthmatic symptoms and prevent airway remodeling when used as an additional treatment to reduce the intake of β 2 -agonists and corticosteroids in order to decrease the harmful side effects of corticosteroids (15,16). However, LT antagonists may be produced naturally and endogenously in the human body, namely lipoxins (LXs).…”

Section: Introductionmentioning

confidence: 99%

Pilot application of lipoxin A4 analog and lipoxin A4 receptor agonist in asthmatic children with acute episodes

Kong

Zhang

et al. 2017

Experimental and Therapeutic Medicine

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Abstract. Previous studies have demonstrated that lipoxin A 4 (LXA 4 ) analogs blocked both airway hyper-responsiveness and pulmonary inflammation in a murine model of asthma. The present pilot study investigated the initial efficacy and safety of inhaled 5(S),6(R)-LXA 4 methyl ester and BML-111, a LXA 4 agonist, in the treatment of asthmatic children with acute episodes. A total of 50 asthmatic children diagnosed with acute moderate asthma were randomly assigned into groups and subjected to an inhalation challenge with pulmicort (n=10), ventolin (n=10), 5(S),6(R)-LXA 4 methyl ester (n=10), BML-111 (n=10) or normal saline as a placebo (n=10). Pulmonary function was assessed prior to and following the challenge. Acute toxicity and safety of the inhaled 5(S),6(R)-LXA 4 methyl ester and BML-111 in normal BALB/c mice were investigated prior to the current pilot study conducted in patients. Following the inhalation challenge, pulmonary function parameters in all groups with the exception of the normal saline-treated group indicated an improvement. The efficacies of 5(S),6(R)-LXA 4 methyl ester and BML-111 were superior to the efficacy of pulmicort but reduced when compared to the efficacy of ventolin with regard to the improvement of pulmonary function following the inhalation challenge. No clinical adverse events were observed in the enrolled patients. All safety parameters in the full blood counts, routine urine and feces examination, electrocardiogram and liver and kidney function tests at baseline and the end of the current study were within normal limits for all patients. No significant differences in kidney or liver function tests were observed in mice treated with 5(S),6(R)-LXA 4 methyl ester and BML-111. Light and electron microscopy demonstrated no airway epithelium or alveolar epithelial cell damage in the treated mice. The present preliminary study of a small sample demonstrates the initial efficacy and safety of inhaled 5(S),6(R)-LXA 4 methyl ester and BML-111 in the treatment of asthmatic children with acute moderate episodes, and suggests that an inhaled LXA 4 analog and LXA 4 receptor agonist may exhibit potential as a novel therapeutic strategy for asthma.

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Section: Introductionmentioning

confidence: 99%

Pilot application of lipoxin A4 analog and lipoxin A4 receptor agonist in asthmatic children with acute episodes

Kong

Zhang

et al. 2017

Experimental and Therapeutic Medicine

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“…eosinophils in serum, FeNO) (12)(13)(14)(15) but not on the basis of direct measurements (e.g. ECP in bronchial lavage or sputum).…”

mentioning

confidence: 99%

A Randomized Controlled Trial on the Effect of Montelukast on Sputum Eosinophil Cationic Protein in Children with Corticosteroid-Dependent Asthma

et al. 2003

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Previous adult studies demonstrated the clinical efficacy of an additional treatment with leukotriene receptor antagonists on steroid-dependent asthma, but there is little knowledge about anti-inflammatory add-on effects within the lung. In this study, we hypothesized that steroid-treated children exhibit a decrease in bronchial inflammation in induced sputum under additional treatment with montelukast. Twenty-five asthmatic children aged 6 to 14 y, who had been taking inhaled corticosteroids (400 -800 g/d budesonide) regularly for at least 12 wk, were randomized to receive additional treatment with either montelukast (5 mg orally, once daily) or placebo over a 4-wk period. As primary efficacy variable, eosinophil cationic protein (ECP) in induced sputum as direct measurement of bronchial inflammation was assessed before and after treatment. To assure a baseline level of inflammation, an ECP concentration above 100 g/L was required. Sputum eosinophil count, concentration of exhaled nitric oxide, urinary excretion of eosinophil protein X, and quality-oflife items were considered as secondary outcome variables. After treatment with montelukast, ECP in sputum was significantly reduced (montelukast: median Ϫ975 g/L [5 to 95% confidence interval: Ϫ4295 to 583 g/L]; placebo: 561 g/L [Ϫ1335 to 3320 g/L]; p Ͻ 0.01) and the quality-of-life score had significantly improved (p Ͻ 0.05) compared with placebo. Partly explained by low baseline levels, no statistically significant change in concentration of exhaled nitric oxide (p Ͼ 0.05), urinary excretion of eosinophil protein X (p Ͼ 0.05), or eosinophil count (p Ͼ 0.05) was found. In conclusion, add-on treatment with montelukast can suppress sputum ECP in children with steroid-dependent asthma, while at the same time an improvement in quality of life items occurs. Asthma is the most common chronic disease in children and results in a considerable burden in the child's daily life (1). Inhaled glucocorticosteroids are the most potent antiinflammatory drugs currently available and are the first-line therapy in patients with chronic asthma (2). However, longterm side effects of inhaled corticosteroids in young children cannot be fully excluded (3). Moreover, several studies have shown a persistent inflammation in steroid-treated asthmatics (4 -7), and it has been postulated that inadequate treatment of airway inflammation may lead to irreversible changes in airway function (8). LTRA such as zafirlukast, pranlukast, and montelukast are able to reduce effects of Cys-LT (leukotriene C4, D4, and E4) and are increasingly used as additional anti-inflammatory drugs. The local pulmonary efficacy of zafirlukast was demonstrated in bronchoscopy-based studies (9, 10). Recently, it has been shown that pranlukast is able to reduce bronchial inflammation assessed by sputum markers in asthmatic adults (11).Montelukast, although frequently used for children, has been evaluated on the basis of indirect measurements (e.g. eosinophils in serum, FeNO) (12-15) but not on the basis of direct measurem...

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“…Em estudo avaliando a eficácia do montelukaste, como monoterapia em crianças de dois a cinco anos de idade, com asma persistente (beta-agonista era necessário seis dias por semana), na dose diária de 4mg, durante estudo de 12 semanas, concluiu-se que o montelukaste diminuiu significativamente o escore diário de sintomas de asma, a necessidade de ß 2 -agonistas, o número de dias com sintomas e a necessidade de corticosteróide de alívio 25 . Em outro grupo de crianças com asma persistente, montelukaste foi bem tolerado, diminuiu os sintomas de asma e o uso de ß2-agonistas e aumentou o número de dias assintomáticos 26 .…”

Section: Modificadores De Leucotrienosunclassified

Prophylactic treatment of asthma

Moura¹,

Camargos²,

Blic³

2002

J Pediatr (Rio J)

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Montelukast added to budesonide in children with persistent asthma: A randomized, double-blind, crossover study

Cited by 162 publications

References 22 publications

Pilot application of lipoxin A4 analog and lipoxin A4 receptor agonist in asthmatic children with acute episodes

Pilot application of lipoxin A4 analog and lipoxin A4 receptor agonist in asthmatic children with acute episodes

A Randomized Controlled Trial on the Effect of Montelukast on Sputum Eosinophil Cationic Protein in Children with Corticosteroid-Dependent Asthma

Prophylactic treatment of asthma

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