Clinical trial NCT06061848: Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Official title: Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Allergic Rhinitis Due to Grass Pollen
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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* withdrawn consent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)

Primary outcomes:
measure: CSMS
timeFrame: 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 outcomes:
measure: CSMS peak pollen season
timeFrame: 15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment.
measure: RQLQ
timeFrame: 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.
measure: VAS (0-10)
timeFrame: 4-6 months before treatment and 6-9 months after treatment
measure: Serolology with immunoglobulins
timeFrame: 1 year before treatment, 4-6 weeks after treatment, 1 year after treatment
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital, ENT department
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, ENT-department
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Lars O Cardell, Professor
role: PRINCIPAL_INVESTIGATOR
References: