ALK Alutard 5-grasses and birch
DrugIntralymphatic injections
Other names: Grass and birch allergen with aluminum adjuvant
NCT Number: NCT04296474
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund, Lund, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intralymphatic injections
Other names: Grass and birch allergen with aluminum adjuvant
intralymphatic injections
Other names: Human albumin
Time frame: 5-6 years after active or placebo ILIT
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
Time frame: 5-6 years after active or placebo ILIT
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
Time frame: Pollen season 5-7 years after active or placebo ILIT
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
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
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: 5-6 years after active or placebo ILIT
Blood test
Time frame: 5-6 years after active or placebo ILIT
Blood test
Time frame: 5-6 years after active or placebo ILIT
Blood samples and lymph node aspirates are investigated with flow cytometry
Lars Olaf Cardell
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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