A double blind randomized placebo controlled study on the efficacy of intralymphatic immunotherapy in the treatment of grasspollen induced allergic rhinitis.

Allergic rhinitis is a globally occurring disease with a still increasing
incidence. The mainstay of treatment is the aimed at symptom reduction using
local or systemic medication. A second treatment modality consists of
immunotherapy in which symptom reduction is achieved by modulating the immune
system. Current immunotherapy protocol make use of intadermal injection or
sublingual allergen application. These protocols necessitate prolonged
participation of patients for up to three years. This gives rise to a high
amount of therapy drop out / failure.
A new approach to allergen sentisation using a shorter strategy of allegen
application wil improve therapy results and overall costs. Intra lymphatic
application of allergens is such a new strategy with promissing results.

In this study we will compare the effect of intra nodal allegen injection with
grass pollen to the intra nodal injection with placebo on symptome scores of
allgic rhinitis (hay fever) in grass allergic patients.

25 patients suffering from allergic rhinitis to grass pollen will receive 3
consecutive intranodal injection with grass pollen (Alutard) in the groin
region. These injections will be given once a month. 25 patients in the control
group will receive placebo injections in a similar fashion. Prior to allergen
injections the level of allergic complaints will be scored using a intranasal
provocation test. Two months after final injection a similar intra nasal
provocation test will be performed. Differences in allergen provocation
reactivity (VAS scores) in pre and post immunotherapy nasal provocation tests,
will be compared between the groups.

allergen provocation tests
blood sampels
nasal biopsy
intranodal groin injection

All participating patients will undergo extra test which are not direct related
to the standard treatment protocol for immunotherapy. The extra tests consist
of one additional allergic skin test, intranasal allergen provocation twice and
one additional blood sample. These test can give rise to mild local allergic
reaction (itching of the skin, redness and / or swelling of the skin, sneezing
and itching of nose / eyes. More invasive tests are biopsy of the nasal mucosa
which can cause minor nose bleeds in some cases and can be treated with minimal
discomfort. The intra nodal injection in the groin area can cause mild local
skin reactions. Systemic allergic reaction (anafylactic shock, astma
exacerbation) to allergen provocation have been sporadically reported. However
in literature no such effect have been reported in the case of intranodal
injection. To prevent the occurrence of these effects patients with instabel
asthma will be excluded from participation. Furthermore allergic sensitization
will be performed at the department of radiology. This department is by nature
triggered to detect and if necessary treat allergic systemic reactions
(anaphylaxis due to contrast allergy).