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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Allergic Rhinitis Due to Grass Pollen

In brief

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 facts

Study ID

NCT06061848

Run by

Lars Olaf Cardell

People needed

360

Starts

2023-02-01

Expected to finish

2031-12-28

Last updated by the study team

2024-10-21

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score >/= 8.
• informed consent

You may not qualify if…

• chronic rhinosinusitis with or without nose polyps
• Previous immunotherapy (SLIT or SCIT)
• BMI > 35
• house dust mite allergy with symptoms
• allergy towards furry animals if exposition cannot be avoided
• 25(OH)Vitamin D levels < 25 or > 75 nmol/L
• use of Vitamin D supplementation or excessive use of sun tanning booths
• mental incapacity to follow study protocol
• other significant disease
• allergy towards study medication
• uncontrolled asthma
• severe atopic dermatitis
• pregnancy or nursing
• autoimmune disease
• hyper IgE-syndrome
• cardiovascular disease
• lung disease
• liver or kidney disease
• hematologic disorder
• metabolic disease
• chronic infectious disese
• medications interacting with the immune system
• cancer
• previous cytostatic therapy
• medication with beta-blockers or ACE-inhibiters, if medication cannot be paused at the day for treatment

Where it is running

• Karolinska University Hospital, ENT-department — Stockholm, Sweden (enrolling)
• Skåne University Hospital, ENT department — Lund, Sweden
• Örebro University Hospital — Örebro, Sweden

Full record on ClinicalTrials.gov

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