The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
3 injections with 4-5 weeks interval.
0,3% human albumin
Allergy Unit, Södra Älvsborgs Hospital
Borås, Sweden
ENT department, Skånes University Hospital Malmö and Lund
Malmo, Sweden
ENT department, Karolinska University Hospital
Stockholm, Sweden
Total daily symptoms and medications score
Difference between active and placebo group in total daily symptoms and medications score during the pollen season.
Time frame: 5-7 months after treatment
Improvement on Visual Analogue Scale (VAS)
Difference in improvement on VAS between active and placebo group.
Time frame: During pollen season and recalled after pollen season, approximately 1 year after the start of treatment.
Change in skin prick test reactivity
Tested with ALK Soluprick. Measured as the wheal area in millimeter for birch- or grass pollen.
Time frame: 4-8 weeks after treatment, 9-12 months after treatment
Change in symptoms score after nasal allergen challenge
0,1 ml of ALK Aquagen Birch or Timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded.
Time frame: 4-8 weeks after treatment, 9-12 months after treatment
Difference between active and placebo group in Quality of Life measured with Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
At peak pollen season after treatment.
Time frame: Up to 7 months after treatment.
Difference between active and placebo group in Quality of Life measured with Sino Nasal Outcome Test -22 (SNOT-22)
At peak pollen season after treatment.
Time frame: Up to 7 months after treatment.
Change in allergen specific S- antibody levels.
IgE, IgG, IgG4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4-8 weeks after treatment, 9-12 months after treatment
Incidence of adverse events graded as mild-moderate-severe
Time frame: From first injection to 30 days after last injection.