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Background and Objective: The orodispersible house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) is being developed for the treatment of HDM respiratory allergic disease. The objective of the 2 phase I trials was to investigate tolerability and the acceptable dose range of HDM SLIT-tablet treatment in adults and children with HDM respiratory allergic disease., Patients and Methods: The trials were randomized, multiple-dose, dose-escalation, double-blind, placebo-controlled phase I trials including patients with HDM-induced asthma, with or without rhinoconjunctivitis. Both trials were registered in EudraCT (Trial 1: 2005-002151-41; Trial 2: 2007-000402-67). Trial 1 included 71 adults (18-63 years) and trial 2 included 72 children (5-14 years). Both trials included 6 dose groups that were randomized 3:1 to active treatment or placebo once daily for 28 days. Adverse events (AEs) were coded in MedDRA (version 8.1 or later). Immunological variables included specific IgE and IgE-blocking factor., Results: No serious AEs were reported. In trial 1 (maximum dose, 32 development units [DU]), 1 patient in the 16 DU group discontinued due to AEs. The entire 32 DU group was discontinued as 1 patient had a severe adverse reaction. In trial 2 (maximum dose, 12 DU), no patients discontinued prematurely. The most frequently reported AEs were mild application-site related events. The total number of events was dose-related within each trial. HDM SLIT-tablet treatment induced changes in immunological parameters in a dose-dependent manner., Conclusions: These trials demonstrate that doses up to 12 DU of HDM SLIT-tablet were tolerated in the selected populations, and thus are suitable for further clinical investigations in adults and children with HDM respiratory allergic disease.

Although health-related quality of life and patient satisfaction are shifting doctors' attention to the patient, the scant number of publications on quality of life questionnaires and allergen immunotherapy contrasts with the quickly growing number of those dealing with this topic and pharmacotherapy. We delivered an original, self-administered patient satisfaction questionnaire to 95 patients (age = 17.7 +/- 7.9 years) suffering from allergic rhinoconjunctivitis (45%) and/or asthma (55%), who had been receiving allergen immunotherapy for more than 1 year (22.2 +/- 10.5 months). The anonymous, voluntary questionnaire was filled in at home; although only 32% were returned, we found no significant differences relating to age, sex, asthma, allergen sensitization or allergen immunotherapy regimen between the source sample and those who replied. Patient expectations, which were scored on a scale of 1 to 10 points, were rather poor, in sharp contrast with patient perception score after treatment (5.4 +/- 1.8 vs. 8.0 +/- 2.0, p < 0.0001). Perception scores did not differ between patients receiving seasonal or perennial allergen immunotherapy, nor did they depend on the duration of treatment. In addition, patient age, sex, diagnosis or sensitization did not appear to influence perceptions. In conclusion, our data suggest that when a voluntary, anonymous questionnaire is used, patients express a poor opinion of allergen immunotherapy, in contrast with high satisfaction after treatment, provided that allergen immunotherapy lasts long enough.