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Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Sponsor: Lars Olaf Cardell
Summary
A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2023-02-01
Completion Date
2031-12-28
Last Updated
2024-10-21
Healthy Volunteers
No
Conditions
Interventions
SLIT Grazax ALK Nordic 75 000 SQ-T
Daily sublingual grass allergen tablets
ILIT + Vitamin D
1 mL of Vicotrat D3, Heyl Pharma, 100 000 IU/mL, as intramuscular injection. Followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections
ILIT + placebo
1 ml of Sodium chloride solution 9 mg/mL as intramuscular injection followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections
Locations (3)
Skåne University Hospital, ENT department
Lund, Sweden
Örebro University Hospital
Örebro, Sweden
Karolinska University Hospital, ENT-department
Stockholm, Sweden