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Clinical Trial
Journal Article
Safety and tolerability of ultra-rush (20 minutes) sublingual immunotherapy in patients with allergic rhinitis and/or asthma.
Allergologia et Immunopathologia 2005 July
BACKGROUND: The safety and good tolerability of sublingual immunotherapy (SLIT) has already been proved in allergic patients, but only one study has investigated the occurrence of immediate adverse reactions in allergic patients after a 2-hour ultra-rush regimen of SLIT performed with a chemically modified extract (sublingual monomeric allergoid, Lais, Lofarma S.p.A., Milan). The objective of the present study was to evaluate the occurrence of immediate adverse reactions in allergic patients after a very fast (20 minutes) ultra-rush regimen of sublingual allergoid SLIT.
METHODS AND RESULTS: We studied 105 patients: 28 children (20 male, mean age 13.3 +/- 2.1 yr) and 77 adults (29 male, mean age 34.7 +/- 9.9 years) with a history of intermittent/persistent rhinitis or intermittent/mild persistent asthma due to House Dust Mite (n = 56), Parietaria (n = 34) and Timothy-grass (n = 15) The build-up ultra-rush phase involved the administration, every five minutes, of increasing doses of the sublingual allergoid SLIT. All patients tolerated the treatment very well. Only one patient out of 105 (0.9%) had a mild local symptoms (gastric pirosis) that occurred 30 minutes after the last initial dose and spontaneously disappeared as the treatment was continued.
CONCLUSIONS: These data show the excellent safety and tolerability profile of an ultra-rush SLIT regimen performed with a chemically modified extract, even when high doses were administered through an extremely short induction phase (20 minutes), thus confirming the previously reported results.
METHODS AND RESULTS: We studied 105 patients: 28 children (20 male, mean age 13.3 +/- 2.1 yr) and 77 adults (29 male, mean age 34.7 +/- 9.9 years) with a history of intermittent/persistent rhinitis or intermittent/mild persistent asthma due to House Dust Mite (n = 56), Parietaria (n = 34) and Timothy-grass (n = 15) The build-up ultra-rush phase involved the administration, every five minutes, of increasing doses of the sublingual allergoid SLIT. All patients tolerated the treatment very well. Only one patient out of 105 (0.9%) had a mild local symptoms (gastric pirosis) that occurred 30 minutes after the last initial dose and spontaneously disappeared as the treatment was continued.
CONCLUSIONS: These data show the excellent safety and tolerability profile of an ultra-rush SLIT regimen performed with a chemically modified extract, even when high doses were administered through an extremely short induction phase (20 minutes), thus confirming the previously reported results.
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