A randomized controlled trial on the effect of montelukast on sputum eosinophil cationic protein in children with corticosteroid-dependent asthma.
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 microg/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 microg/L was required. Sputum eosinophil count, concentration of exhaled nitric oxide, urinary excretion of eosinophil protein X, and quality-of-life items were considered as secondary outcome variables. After treatment with montelukast, ECP in sputum was significantly reduced (montelukast: median -975 microg/L [5 to 95% confidence interval: -4295 to 583 microg/L]; placebo: 561 microg/L [-1335 to 3320 microg/L]; p < 0.01) and the quality-of-life score had significantly improved (p < 0.05) compared with placebo. Partly explained by low baseline levels, no statistically significant change in concentration of exhaled nitric oxide (p > 0.05), urinary excretion of eosinophil protein X (p > 0.05), or eosinophil count (p > 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.
Mathildenstrabetae 1, D-79106 Freiburg, Germany.
Elke
E
Strauch
Olaf
O
Moske
Sandra
S
Thoma
Karin
K
Storm Van's Gravesande
Gabriele
G
Ihorst
Matthias
M
Brandis
Joachim
J
Kuehr
D000085:Acetates / Q000008:administration & dosage*; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy* / Q000276:immunology; D001798:Blood Proteins / Q000378:metabolism*; D019819:Budesonide / Q000008:administration & dosage; D002648:Child; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D047091:Eosinophil Granule Proteins; D004804:Eosinophils / Q000166:cytology / Q000276:immunology / Q000378:metabolism*; D005260:Female; D006801:Humans; D008297:Male; D011804:Quinolines / Q000008:administration & dosage*; D012260:Ribonucleases / Q000378:metabolism*; D013183:Sputum / Q000166:cytology / Q000276:immunology / Q000378:metabolism; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D001798:Blood Proteins; D003521:Cyclopropanes; D047091:Eosinophil Granule Proteins; D011804:Quinolines; D013440:Sulfides; D019819:Budesonide; D012260:Ribonucleases; C093875:montelukast