Safety of ultra-rush titration of sublingual immunotherapy in asthmatic children with tree-pollen allergy.
The recommendation to use sublingual-swallow immunotherapy (SLIT) in children and adults with allergic rhinitis has been established over the past decade. Recently, ultra-rush titration of SLIT has become more and more common, raising concerns about its safety in children with asthma. Fifty-four children with asthma and adolescents aged 6–14 with documented allergic disease because of tree pollen (birch and possibly alder and/or hazel) from 14 study centers in Germany participated in a randomized, double-blind, and placebo-controlled study. Twenty-seven were randomized to receive SLIT with standardized birch pollen allergen extract and the other 27 to receive placebo. An ultra-rush high-dose SLIT titration regimen reaching the maintenance dose of 300 index of reactivity (IR) within 90 min (30–90–150–300 IR) was used. The difference in mean PFR changes during ultra-rush titration between SLIT and placebo was not significant (p = 0.056). A 95% probability that SLIT does not decrease PFR during ultra-rush titration was demonstrated. Neither anaphylactic shock nor else serious systemic reactions to the study drug occurred. No serious adverse event assessed by the investigator as related to study drug treatment was reported.
Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany. ralph@moesges.de
Ralph
R
Mösges
Vera
V
Graute
Hildegard
H
Christ
Hans-Jochen
HJ
Sieber
Ulrich
U
Wahn
Bodo
B
Niggemann
D000286:Administration, Sublingual; D000293:Adolescent; D000485:Allergens / Q000008:administration & dosage / Q000009:adverse effects; D001249:Asthma / Q000150:complications / Q000276:immunology* / Q000628:therapy*; D002648:Child; D003888:Desensitization, Immunologic; D054796:Drug Dosage Calculations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D011058:Pollen / Q000009:adverse effects; D012129:Respiratory Function Tests; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications / Q000276:immunology* / Q000628:therapy*; D014197:Trees / Q000276:immunology
D000485:Allergens