52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.
Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed. Objective: To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass. Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Intralymphatic injections
intralymphatic injections
Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund
Lund, Sweden
Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö
Malmo, Sweden
ENT department, Karolinska University Hospital
Stockholm, Sweden
Nasal grass allergen provocation
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
Time frame: 5-6 years after active or placebo ILIT
Nasal birch allergen provocation
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
Time frame: 5-6 years after active or placebo ILIT
Combined symptoms and medciations score
Ranging from 0- no symptoms and medication, to 6- maximum symptoms and medication.
Time frame: Pollen season 5-7 years after active or placebo ILIT
Rhinoconjunctivitis quality of life questionnaire
Average score of 28 questions ranging from 0-no impairment of quality of life, to 6- maximum impairment of quality of life.
Time frame: Pollen season 5-7 years after active or placebo ILIT
Sinonasal outcome test quality of life questionnaire
Sum of 22 questions. The score ranges from 0-no impairment of quality of life, to 110- maximum impairment of quality of life.
Time frame: Pollen season 5-7 years after active or placebo ILIT
Allergen specific IgE
Blood test
Time frame: 5-6 years after active or placebo ILIT
Allergen specific IgG4
Blood test
Time frame: 5-6 years after active or placebo ILIT
T-cell and basophil activation
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Blood samples and lymph node aspirates are investigated with flow cytometry
Time frame: 5-6 years after active or placebo ILIT