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

BACKGROUND: Enzyme potentiated desensitization, in which beta-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 (TO), 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<. 01). CONCLUSIONS: BG immunotherapy is efficacious, safe, and well tolerated in allergic children. Moreover, good compliance with the administration of 2 doses per year and the lack of significant side effects makes the benefit/risk ratio of this treatment particularly favorable.

Adolescent↗

Safety, tolerability and efficacy of sublingual allergoid immunotherapy with a 4-day shortened build-up phase.

BACKGROUND: Sublingual specific immunotherapy (SLIT) with monomeric allergoid has shown to be safe and effective the studies performed so far. The build-up phase, however, is rather time consuming mainly if performed with the conventional schedule of 14 weeks. AIMS OF STUDY: We evaluated the possibility of shortening and simplifying this phase, through a new build-up scheme of only 4 days, as well as the persistence of the allergoid SLIT efficacy after 12 months. METHODS: Thirty-nine patients (26 M, 13 F, mean age 20.5 years, range 6-49) with a history of moderate/severe rhinitis with or without mild asthma due to perennial and/or seasonal allergens entered the study. The posological schedule, adopting only 1,000 AU tablets, was the following: 1/2 tablet the 1st day; 1/2 table twice the second day; 1/2 table plus 1 table the 3rd day, 1 tablet twice the 4th day; 1 tablet twice weekly from the 5th to the 365th day (maintenance therapy). RESULTS: Only two mild adverse reactions occurred during the initial phase which disappeared with the prosecution of the treatment. During the maintenance therapy no adverse event was observed. Symptoms improved consistently and drug consumption was reduced in most of the patients. CONCLUSIONS: The 4-day shortened build-up phase resulted to be safe, well tolerated and effective, already after one year of treatment.

Administration, Sublingual↗