The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo. \*\*\*IMPORTANT INFORMATION!\*\*\* The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.
40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.
Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund
Lund, Sweden
ENT-department, Karolinska University Hospital Huddinge (ENT-department B51)
Stockholm, Sweden
Mean combined daily symptoms-and-medications-score
Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).
Time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Mean total daily symptoms score
Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale)
Time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Mean total daily medications score
Daily scoring of medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).
Time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Change in subjective allergic symptoms following nasal allergen provocation
The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation.
Time frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.
Effects on quality of life
Juniper Rhinitis quality of life questionnaire (RQLQ) questionnaires
Time frame: During peak pollen season which will be up to 6 months after completed treatment.
Short term change of skin reactivity
Skin prick test
Time frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.
S-IgE Grass or Birch
Time frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
S-IgG4 Grass or Birch
Time frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
Registration of adverse event
Time frame: From the first injection to 30 days after the last injections has been given
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