A double-blind randomized placebo-controlled trial with short-term β-glucuronidase therapy in children with chronic rhinoconjunctivitis and/or asthma due to dust mite allergy

Elena Galli, M. S. Bassi, E. Mora, M. Martelli, S. Gianni, G. Auricchio, E. Arabito, P. Rossi

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Enzyme potentiated desensitization, in which β-glucuronidase (BG) is administered with low doses of mixed allergens, was proposed in the 1970s for specific immunotherapy. The BG currently commercially available in a purified and standardized preparation devoid of any allergen has been suggested as a regulator in the allergic immune response, acting on the cytokine-network of type 2 helper T cells. A double-blind trial with a single-dose of BG proved effective in preventing symptoms in adult patients with rhinoconjunctivitis due to grass pollens. Objective: The aim of this randomized double-blind placebo-controlled trial was to confirm the safety and effectiveness of double-dose intradermal BG immunotherapy in preventing symptoms in children suffering from chronic rhinoconjunctivitis and/or asthma due to dust mite. Method: We randomized 125 children with dust-mite related chronic rhinoconjunctivitis and/or asthma to the BG treated group (67) or the placebo group (58). All patients were screened before treatment (T0), at BG or placebo administration (T1 and T3), and at 3 and 9 months after T1 (T2 and T4). Drug intake and bronchial, nasal and ocular symptoms were recorded in a diary. Results: Patients in both groups completed the study and BG treatment was well tolerated without side effects. Significant differences in symptoms were observed, in particular for conjunctivitis (P=.008). The total drug intake for allergic symptoms was significantly lower in the treated group than in the placebo group (P

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Mites
Glucuronidase
Dust
Hypersensitivity
Asthma
Randomized Controlled Trials
Placebos
Immunotherapy
Allergens
Th2 Cells
Conjunctivitis
Therapeutics
Pollen
Poaceae
Nose
Pharmaceutical Preparations
Cytokines
Safety
Enzymes

Keywords

  • β-glucuronidase
  • Allergic diseases
  • Children
  • Immunotherapy

ASJC Scopus subject areas

  • Immunology and Allergy

Cite this

@article{3e6446750c874dd194699c287f7330cd,
title = "A double-blind randomized placebo-controlled trial with short-term β-glucuronidase therapy in children with chronic rhinoconjunctivitis and/or asthma due to dust mite allergy",
abstract = "Background: Enzyme potentiated desensitization, in which β-glucuronidase (BG) is administered with low doses of mixed allergens, was proposed in the 1970s for specific immunotherapy. The BG currently commercially available in a purified and standardized preparation devoid of any allergen has been suggested as a regulator in the allergic immune response, acting on the cytokine-network of type 2 helper T cells. A double-blind trial with a single-dose of BG proved effective in preventing symptoms in adult patients with rhinoconjunctivitis due to grass pollens. Objective: The aim of this randomized double-blind placebo-controlled trial was to confirm the safety and effectiveness of double-dose intradermal BG immunotherapy in preventing symptoms in children suffering from chronic rhinoconjunctivitis and/or asthma due to dust mite. Method: We randomized 125 children with dust-mite related chronic rhinoconjunctivitis and/or asthma to the BG treated group (67) or the placebo group (58). All patients were screened before treatment (T0), at BG or placebo administration (T1 and T3), and at 3 and 9 months after T1 (T2 and T4). Drug intake and bronchial, nasal and ocular symptoms were recorded in a diary. Results: Patients in both groups completed the study and BG treatment was well tolerated without side effects. Significant differences in symptoms were observed, in particular for conjunctivitis (P=.008). The total drug intake for allergic symptoms was significantly lower in the treated group than in the placebo group (P",
keywords = "β-glucuronidase, Allergic diseases, Children, Immunotherapy",
author = "Elena Galli and Bassi, {M. S.} and E. Mora and M. Martelli and S. Gianni and G. Auricchio and E. Arabito and P. Rossi",
year = "2006",
language = "English",
volume = "16",
pages = "345--350",
journal = "Journal of Investigational Allergology and Clinical Immunology",
issn = "1018-9068",
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}

TY - JOUR

T1 - A double-blind randomized placebo-controlled trial with short-term β-glucuronidase therapy in children with chronic rhinoconjunctivitis and/or asthma due to dust mite allergy

AU - Galli, Elena

AU - Bassi, M. S.

AU - Mora, E.

AU - Martelli, M.

AU - Gianni, S.

AU - Auricchio, G.

AU - Arabito, E.

AU - Rossi, P.

PY - 2006

Y1 - 2006

N2 - Background: Enzyme potentiated desensitization, in which β-glucuronidase (BG) is administered with low doses of mixed allergens, was proposed in the 1970s for specific immunotherapy. The BG currently commercially available in a purified and standardized preparation devoid of any allergen has been suggested as a regulator in the allergic immune response, acting on the cytokine-network of type 2 helper T cells. A double-blind trial with a single-dose of BG proved effective in preventing symptoms in adult patients with rhinoconjunctivitis due to grass pollens. Objective: The aim of this randomized double-blind placebo-controlled trial was to confirm the safety and effectiveness of double-dose intradermal BG immunotherapy in preventing symptoms in children suffering from chronic rhinoconjunctivitis and/or asthma due to dust mite. Method: We randomized 125 children with dust-mite related chronic rhinoconjunctivitis and/or asthma to the BG treated group (67) or the placebo group (58). All patients were screened before treatment (T0), at BG or placebo administration (T1 and T3), and at 3 and 9 months after T1 (T2 and T4). Drug intake and bronchial, nasal and ocular symptoms were recorded in a diary. Results: Patients in both groups completed the study and BG treatment was well tolerated without side effects. Significant differences in symptoms were observed, in particular for conjunctivitis (P=.008). The total drug intake for allergic symptoms was significantly lower in the treated group than in the placebo group (P

AB - Background: Enzyme potentiated desensitization, in which β-glucuronidase (BG) is administered with low doses of mixed allergens, was proposed in the 1970s for specific immunotherapy. The BG currently commercially available in a purified and standardized preparation devoid of any allergen has been suggested as a regulator in the allergic immune response, acting on the cytokine-network of type 2 helper T cells. A double-blind trial with a single-dose of BG proved effective in preventing symptoms in adult patients with rhinoconjunctivitis due to grass pollens. Objective: The aim of this randomized double-blind placebo-controlled trial was to confirm the safety and effectiveness of double-dose intradermal BG immunotherapy in preventing symptoms in children suffering from chronic rhinoconjunctivitis and/or asthma due to dust mite. Method: We randomized 125 children with dust-mite related chronic rhinoconjunctivitis and/or asthma to the BG treated group (67) or the placebo group (58). All patients were screened before treatment (T0), at BG or placebo administration (T1 and T3), and at 3 and 9 months after T1 (T2 and T4). Drug intake and bronchial, nasal and ocular symptoms were recorded in a diary. Results: Patients in both groups completed the study and BG treatment was well tolerated without side effects. Significant differences in symptoms were observed, in particular for conjunctivitis (P=.008). The total drug intake for allergic symptoms was significantly lower in the treated group than in the placebo group (P

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