title: Sublingual immunotherapy with a latex extract in paediatric patients: a double-blind, placebo-controlled study.
abstract: BACKGROUND
  Natural rubber latex (NRL) allergy remains an important allergic disease triggering urticaria, asthma, angioedema and anaphylaxis. Specific immunotherapy can help to solve problems related to NRL allergy. So far, no controlled clinical trials have been performed in children suffering from NRL allergy.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of sublingual immunotherapy (SLIT) with a commercial NRL extract in children with NRL allergy.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled, 12-month trial.
  
  
  METHODS
  Twenty-six children (aged 4-15 years) with NRL allergy, who had cutaneous and/or respiratory symptoms, including oral allergy syndrome to fruits containing cross-reactive allergens, were recruited. Twelve children were randomized to SLIT with a commercial NRL extract and eight to placebo (3:2). An additional six children with NRL allergy served as untreated controls.
  
  
  METHODS
  A glove use test was utilized to monitor skin and systemic symptoms triggered by NRL exposure at baseline and 3, 6, 9 and 12 months later. Oral allergy symptoms were also monitored.
  
  
  RESULTS
  No side effects related to treatments were observed in any patient. A significant improvement of symptom score in treated patients in comparison with baseline values was observed at 3 months (p = 0.01) and consolidated after 1 year of treatment (p = 0.0005). In comparison with placebo, significant improvements were observed starting at 9 months from study start (p = 0.015) and at 12 months (p = 0.005). The number of foods triggering oral allergy symptoms increased in placebo and control subjects, but not in active treated patients (p = 0.05).
  
  
  CONCLUSIONS
  Latex SLIT was safe and efficacious in paediatric patients with NRL allergy.
authors.affiliation: Paediatric Allergy and Pneumology Centre, Anna Meyer Children's Hospital, Florence, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Bernardini
authors.forename: Patrizia
authors.initials: P
authors.lastname: Campodonico
authors.forename: Samuele
authors.initials: S
authors.lastname: Burastero
authors.forename: Chiara
authors.initials: C
authors.lastname: Azzari
authors.forename: Elio
authors.initials: E
authors.lastname: Novembre
authors.forename: Neri
authors.initials: N
authors.lastname: Pucci
authors.forename: Cristina
authors.initials: C
authors.lastname: Massai
authors.forename: Maurizio
authors.initials: M
authors.lastname: De Martino
authors.forename: Alberto
authors.initials: A
authors.lastname: Vierucci
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D017575:Gloves, Protective / Q000009:adverse effects; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000628:therapy*; D007073:Immunoglobulin E / Q000097:blood; D007167:Immunotherapy / Q000379:methods*; D007840:Latex / Q000008:administration & dosage* / Q000737:chemistry / Q000627:therapeutic use; D020315:Latex Hypersensitivity / Q000628:therapy*; D010919:Placebos; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use; D012882:Skin Tests; D016896:Treatment Outcome
chemical_list: D007840:Latex; D010919:Placebos; D010936:Plant Extracts; D007073:Immunoglobulin E