Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLars Olaf Cardell

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

360 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Lars Olaf Cardell

Lead sponsor

Karolinska Institutet

Sponsor institution