Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SLIT Grazax ALK Nordic 75 000 SQ-T, ILIT + Vitamin D, ILIT + placebo.
- Who it may be relevant to
- Registry conditions: Allergic Rhinitis Due to Grass Pollen. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug SLIT Grazax ALK Nordic 75 000 SQ-T
Daily sublingual grass allergen tablets - Drug 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 - Drug 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
Primary outcome measures
- CSMS [Time frame: 60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.]
Secondary outcome measures (4)
- CSMS peak pollen season [Time frame: 15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment.]
- RQLQ [Time frame: 60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.]
- VAS (0-10) [Time frame: 4-6 months before treatment and 6-9 months after treatment]
- Serolology with immunoglobulins [Time frame: 1 year before treatment, 4-6 weeks after treatment, 1 year after treatment]
Eligibility criteria
Inclusion criteria
- moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score >/= 8.
- informed consent
Exclusion criteria
- 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
- drug or alcohol abuse
- intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1
- withdrawn consent
Exclusion Criteria only for ILIT group (due to vitamin D treatment)
- medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs, glycosides, orlistat, statines, thiazide diuretics)
- tendency for formation of kidney stones
- hyperparathyroidism or other disease conferring risk of hypercalcemia
- hereditary pseudohypoparathyroidism with decreased phosphorous secretion
- malabsorption or bowel disease with diarrhea
- Mb Paget, osteoporosis or sarcoidosis
- skin disease at the groin (where the treatment will be injected)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Sweden · 3 centers
- Skåne University Hospital, ENT department — Lund
- Örebro University Hospital — Örebro
- Karolinska University Hospital, ENT-department — Stockholm
Identifiers
NCT: NCT06061848 · Dnr KS: K2021-5840