title: A randomized, double-blind trial of the effect of glucocorticoid, antileukotriene and beta-agonist treatment on IL-10 serum levels in children with asthma.
abstract: BACKGROUND
  Levels of an immunoregulatory and anti-inflammatory cytokine IL-10 are reduced in asthmatic airways, potentially contributing to more intense inflammation. Triamcinolone has anti-inflammatory properties and the anti-inflammatory effects of montelukast and formoterol have been discussed.
  
  
  OBJECTIVE
  The purpose of this study was to define the effect of treatment with triamcinolone, montelukast and formoterol on the serum level of IL-10, eosinophil blood counts, eosinophil cationic response (ECP) and clinical parameters (symptom score, FEV1 and PC20H) in children with moderate asthma.
  
  
  METHODS
  An 8-week, placebo-controlled and randomized, double-blind trial was carried out. The subjects were 91 children with moderate atopic asthma who were allergic to dust mite. Patients were randomly allocated to receive 400 microg triamcinolone (n = 19), 5 or 10 mg (according to age) montelukast (n = 18), 24 microg formoterol (n = 18) or placebo (n = 36).
  
  
  RESULTS
  Seventy-nine children completed the study. After treatment with triamcinolone and montelukast the level of IL-10 in blood serum significantly increased, eosinophil blood counts and ECP levels significantly decreased and all clinical parameters improved; treatment with formoterol had no effect on IL-10 level, eosinophil blood counts in serum and bronchial hyper-reactivity; ECP level significantly decreased after treatment and asthma symptoms and FEV1 improved significantly. Mean IL-10 levels in serum before and after treatment with triamcinolone were 7.23 pg/mL with 95% CI, 6.74 -7.72% and 14.24 pg/mL with 95% CI, 11.6-16.88%, respectively (P < 0.001); with montelukast they were 6.59 pg/mL with 95% CI, 6.26-7.23% and 10.94 pg/mL with 95% CI, 8.24-12.65%, respectively (P < 0.002); with formoterol they were 7.06 pg/mL with 95% CI, 6.61-7.52% and 7.04 pg/mL with 95% CI, 6.15-7.93%. We found statistically significant correlations between serum level of IL-10 and serum level of ECP after treatment with triamcinolone and montelukast.
  
  
  CONCLUSIONS
  This study demonstrates that one possible way by which triamcinolone and montelukast contribute to inhibition of inflammation is by increasing IL-10 levels.
authors.affiliation: Department of Paediatrics and Allergy, The M. Curie Hospital, 35 Parzeczewska Str. 95-100 Zgierz, Poland. interna@wss.zgierz.pl
authors.forename: I
authors.initials: I
authors.lastname: Stelmach
authors.forename: J
authors.initials: J
authors.lastname: Jerzynska
authors.forename: P
authors.initials: P
authors.lastname: Kuna
mesh_terms: D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000097:blood* / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D001798:Blood Proteins / Q000032:analysis; D002648:Child; D003521:Cyclopropanes; D004311:Double-Blind Method; D047091:Eosinophil Granule Proteins; D004804:Eosinophils / Q000473:pathology; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D016753:Interleukin-10 / Q000097:blood*; D007958:Leukocyte Count; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D008297:Male; D011804:Quinolines / Q000627:therapeutic use*; D012260:Ribonucleases; D013440:Sulfides; D014221:Triamcinolone / Q000627:therapeutic use*
chemical_list: D000085:Acetates; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D001798:Blood Proteins; D003521:Cyclopropanes; D047091:Eosinophil Granule Proteins; D004983:Ethanolamines; D005938:Glucocorticoids; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D016753:Interleukin-10; D014221:Triamcinolone; D012260:Ribonucleases; C093875:montelukast; D000068759:Formoterol Fumarate