title: Montelukast treatment may alter the early efficacy of immunotherapy in children with asthma.
abstract: BACKGROUND
  Allergen-specific immunotherapy (SIT) is the only available potentially curative approach in the management of allergic diseases. Therapies that boost regulatory T cell induction during SIT might further enhance its effectiveness.
  
  
  OBJECTIVE
  The purpose of this study was to assess the effect of montelukast treatment on early clinical and immunologic effects of allergen-specific immunotherapy in children with asthma.
  
  
  METHODS
  It was a randomized, double-blind, placebo-controlled trial conducted in 36 children with asthma and allergy to house dust mites who required from 400 to 800 microg of inhaled budesonide per day during the 7-month run-in period. Patients were randomly allocated to receive 5 mg montelukast daily (n = 18) or placebo (n = 18) as an addition to inhaled corticosteroid (ICS) treatment during the 3-month build-up phase of SIT, when modification of ICS doses was not allowed. During the 7 months of the maintenance phase of SIT, ICS doses were adjusted to control the asthma symptoms.
  
  
  RESULTS
  After 12 months of SIT, a reduction of the median daily ICS dose, necessary to control asthma symptoms, was 16.7% grater in patients from the placebo group than in patients from the montelukast group. Intervention with montelukast significantly impaired the induction of regulatory T lymphocytes. During the build-up phase of SIT, patients in the placebo group frequently experienced an increase in asthma symptoms leading to exclusions from the per protocol population.
  
  
  CONCLUSIONS
  Our study failed to show a beneficial effect of montelukast on SIT. In fact, quite the opposite occurred: compared with placebo, montelukast intervention led to less effectiveness of SIT.
authors.affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland.
authors.forename: Paweł
authors.initials: P
authors.lastname: Majak
authors.forename: Błazej
authors.initials: B
authors.lastname: Rychlik
authors.forename: Lukasz
authors.initials: L
authors.lastname: Pułaski
authors.forename: Andrzej
authors.initials: A
authors.lastname: Błauz
authors.forename: Brzozowska
authors.initials: B
authors.lastname: Agnieszka
authors.forename: Monika
authors.initials: M
authors.lastname: Bobrowska-Korzeniowska
authors.forename: Piotr
authors.initials: P
authors.lastname: Kuna
authors.forename: Iwona
authors.initials: I
authors.lastname: Stelmach
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000280:Administration, Inhalation; D000818:Animals; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage; D039741:Antigens, Dermatophagoides / Q000276:immunology / Q000627:therapeutic use*; D001249:Asthma / Q000276:immunology / Q000503:physiopathology / Q000628:therapy*; D019819:Budesonide / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D002648:Child; D003521:Cyclopropanes; D003888:Desensitization, Immunologic; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008213:Lymphocyte Activation; D039981:Pyroglyphidae / Q000276:immunology; D011804:Quinolines / Q000008:administration & dosage*; D013440:Sulfides; D050378:T-Lymphocytes, Regulatory / Q000276:immunology*; D013997:Time Factors
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D039741:Antigens, Dermatophagoides; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D019819:Budesonide; C093875:montelukast