Sublingual immunotherapy with a latex extract in paediatric patients: A double-blind, placebo-controlled study

Roberto Bernardini, Patrizia Campodonico, Samuele Burastero, Chiara Azzari, Elio Novembre, Neri Pucci, Cristina Massai, Maurizio De Martino, Alberto Vierucci

Research output: Contribution to journalArticle

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. Objectives: To evaluate the safety and efficacy of sublingual immunotherapy (SLIT) with a commercial NRL extract in children with NRL allergy. Research design: Randomized, double-blind, placebo-controlled, 12-month trial. Patients and 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. Main outcomes measures: 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). Conclusion: Latex SLIT was safe and efficacious in paediatric patients with NRL allergy.

Original languageEnglish
Pages (from-to)1515-1522
Number of pages8
JournalCurrent Medical Research and Opinion
Volume22
Issue number8
DOIs
Publication statusPublished - Aug 2006

Keywords

  • Allergy
  • Children
  • Latex
  • Randomized controlled trial
  • Sublingual immunotherapy

ASJC Scopus subject areas

  • Medicine(all)

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    Bernardini, R., Campodonico, P., Burastero, S., Azzari, C., Novembre, E., Pucci, N., Massai, C., De Martino, M., & Vierucci, A. (2006). Sublingual immunotherapy with a latex extract in paediatric patients: A double-blind, placebo-controlled study. Current Medical Research and Opinion, 22(8), 1515-1522. https://doi.org/10.1185/030079906X115711