Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: A double-blind, placebo-controlled trial
Sublingual immunotherapy (SLIT) is increasingly being used for the treatment of allergic rhinitis, but there are conflicting study results demonstrating clinically relevant efficacy.
To show clinical efficacy and safety of a new high-dose grass pollen preparation for SLIT.
In a 2-year, double-blind, placebo-controlled trial, 185 subjects with rhinitis or rhinoconjunctivitis, with or without asthma, were treated with a recently developed, high-dose, 6-grass pollen mixture for SLIT once daily.
The primary end point, a combined symptom-medication score, showed almost no change in the placebo group during a 42-day evaluation period in the grass pollen season from 2003 to 2005, whereas active treatment was associated with a significant and clinically relevant improvement (full analysis set, P = .01; main data set, P = .002). The effect was irrespective of asthma diagnosis. Allergen-specific IgE showed no difference in both groups, and specific IgG4 and IgG1 increased with active treatment in the first and second study years compared with placebo, clearly indicating the immunogenic effect of the active treatment. The SLIT was well tolerated. No serious adverse drug reactions occurred.
High-dose, sublingual, specific immunotherapy with an extract of a 6-grass pollen mixture showed a significant and clinically relevant improvement in subjects with grass pollen-associated rhinitis or rhinoconjunctivitis, with or without asthma. The treatment with the sublingual solution was well tolerated.
Available from: Dietrich Häfner
- "The first study was performed with sublingual immunotherapy (SLIT) of the high dose grass pollen preparation (ALLERSLIT® forte) (SLIT 6-grass study) and included 185 patients [6,7]. Mean age of patients was 33.2 years (SD 10.3, range 17–59); 63% of patients were male, 37% female. "
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A set of standard clinical chemistry and hematology parameters are usually measured during clinical studies. The major outcome of these standard tests is to control that the drug investigated does not lead to pathophysiological changes in respective organs or blood. In some cases based on scientific rationale such tests may not be needed. In this paper we report on a standard set of clinical chemistry and hematology laboratory parameters measured before and after treatment in three different immunotherapy studies, representing different routes of administration and different formulations.
Thirteen hematological laboratory parameters and eight clinical chemistry parameters were evaluated from three double-blind, placebo-controlled, randomized, multi-centre, phase III studies. The three studies include one with sublingual immunotherapy (n = 185), one subcutaneous immunotherapy trial with an aluminium hydroxide-adsorbed recombinant hypoallergenic Bet v1-FV (n = 211) and one with pre-seasonal subcutaneous immunotherapy with a 6-grass pollen allergoid (n = 154).
Allergen specific immunotherapy with both administration forms and formulations respectively did not show any influence on any of the 21 laboratory parameters analyzed. Few patients had a change in laboratory parameters from within normal range at baseline to either below or above at end-of-treatment. No differences between active and placebo were seen with respect to number of patients with such a change.
This study with different preparations and routes of application indicates that the value of repeated measurements of standard clinical chemistry and hematology parameters during allergen immunotherapy should be discussed further.
Available from: F. Friedrichs
- "In current studies the increase of factors that inhibit the binding of IgE to allergens was observed  . Under SLIT the increase in allergen-specific IgG-antibodies and IgG 4 antibodies can differ  . In SLIT with a grass pollen extract in tablet form the allergen-specific IgE-antibodies were significantly increased above the value observed with natural pollen concentrations ( " boost " ) . "
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ABSTRACT: The protospec unifies the concepts of requirements specification
and prototype into a single software engineering process. An example of
the use of the protospec concept for requirements specification within
expert systems development domain is presented. The requirements
specification resulting from this example is evaluated from both a user
and a software engineering point of view. The result is compared to
results for three other specification approaches
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