Pollen Allergy Clinical Trial
Official title:
A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens
The aim of this clinical trial is to show safety and efficacy of the allergoid preparation of birch pollen allergens in the treatment of birch allergic patients in a representative number of patients.
Type I allergy is an immune-disorder which stems from the formation of IgE antibodies
against proteins and glycoproteins from plants, insects, animals and fungi, most of which
for healthy subjects are considered to be harmless. However, in allergic patients the
cross-linking of specific IgE-antibodies on effector cells by allergens activates an
immunological cascade leading to the symptoms of Type I allergy including rhinitis,
conjunctivitis, asthma, and anaphylactic shock. Pollens from wind-pollinated plants
including trees, grasses and weeds, are amongst the most frequent and potent elicitors of
Type I allergy. It is not possible to avoid exposure to these pollens and therefore the
symptoms that patients inevitably suffer must be treated with either symptomatic medication
or allergen specific immunotherapy.
The Betulaceae family includes the genera Alnus (alder), Betula (birch) and Corylus (hazel).
Trees belonging to these genera are widespread in middle and northern Europe and, in
combination with the fact that they shed large quantities of wind-borne pollen, leads to
their allergenic significance. The prevalence of sensitisation to birch pollen has been
studied, and in the case of a middle European (Viennese) population, for example, it has
been demonstrated that approximately 40 % of patients with allergic rhinitis are sensitised.
Although the pollen season for any one genera seldom lasts for more than a few weeks, the
well-documented cross-reactivity between the different Betulaceae and other tree pollens of
the Fagales order contributes to a protracted season of symptoms for many allergic patients.
Allergoids are prepared by chemical modification of partially purified native aqueous
aller-gen extracts. Native allergen extracts are depleted of components with a molecular
mass of less than 5000 Dalton by diafiltration prior to chemical modification with
aldehydes. The modification causes a substantial reduction in the allergenicity of the
extract as can be judged by skin prick testing, provocation testing, histamine release from
sensitised leukocytes and measurement of IgE-binding activity by RAST-inhibition. However,
immunogenic activity and T-cell reactivity are retained. These properties enable allergoids
to be used as a basis for allergen specific immunotherapy with a reduced risk of inducing
IgE-mediated side-reactions and the possibility of administering larger doses of immunogen
over a shorter time course than with native allergens.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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