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Background  In sublingual immunotherapy, optimal doses are a key factor for therapeutic outcomes. The aim of this study with tablets containing carbamylated monomeric house dust mite allergoids was to determine the most effective and safe dose.    Methods  In this double‐blind, placebo‐controlled dose‐finding study, 131 patients with house dust mite‐induced allergic rhinoconjunctivitis were randomized to 12‐week treatments with 300  UA /day, 1000  UA /day, 2000  UA /day, 3000  UA /day or placebo. Conjunctival provocation tests ( CPT ) were performed before, during and after treatment. The change in mean allergic severity (primary endpoint), calculated from the severity of the  CPT  reaction, and the proportion of patients with an improved  CPT  threshold (secondary endpoint) determined the treatment effect.    Results  The mean allergic severity decreased in all groups, including the placebo group. It was lower in all active treatment groups (300  UA /day: 0.14, 1000  UA /day: 0.15, 2000  UA /day: 0.10, 3000  UA /day: 0.15) than in the placebo group (0.30). However, this difference was not statistically significant ( P  < 0.1). The percentage of patients with an improved  CPT  threshold was higher in the active treatment groups (300  UA /day: 73.9%; 1000  UA /day: 76.0%; 2000  UA /day: 88.5%; 3000  UA /day: 76.0%) than in the placebo group (64.3%). The difference between placebo and 2000  UA /day was statistically significant ( P  = 0.04). In 13 (10%) exposed patients, a total of 20 treatment‐related adverse events of mild severity were observed.    Conclusions  The 12‐week daily treatment using 2000  UA /day monomeric allergoid sublingual tablets is well tolerated and reduces the  CPT  reaction in house dust mite‐allergic patients.

A 12‐week DBPC dose‐finding study with sublingual monomeric allergoid tablets in house dust mite‐allergic patients