15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.
The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT. The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires. The first part of the study is completed and published (PMID: 23374268)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection
0.1 mL of ALK Diluent as an intralymphatic injection
Allergy Unit, Södra Älvsborgs Hospital
Borås, Sweden
Change in the serum-level of timothy specific IgG4 after 1 month
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Time frame: Change between baseline and 1 month after treatment.
Change in the serum-level of timothy specific IgG4 after 9 months
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Time frame: Change between baseline and 9 months after treatment.
Change in the serum-level of timothy specific IgG4 2 months after booster
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Time frame: Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).
Change in the serum-level of timothy specific IgG4 10 months after booster
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Time frame: Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).
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