About this trial
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.
Eligibility criteria
Qualifiers
moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score >/= 8.
informed consent
Disqualifiers
chronic rhinosinusitis with or without nose polyps
Previous immunotherapy (SLIT or SCIT)
BMI > 35
house dust mite allergy with symptoms
Trial design
Treatments tested in this trial
- SLIT Grazax ALK Nordic 75 000 SQ-T
- ILIT + Vitamin D
- ILIT + placebo
Treatment groups
Sponsors and collaborators
Lars Olaf Cardell
Lead sponsor
Karolinska Institutet
Sponsor institution