Back to resultsSublingual Immunotherapy Compared to Intralymphatic Immunotherapy With Concomitant Vitamin D, a Randomised Placebo Controlled Study (ILIT vs SLIT)
Primary Purpose
Allergic Rhinitis Due to Grass Pollen
Status
Recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
SLIT Grazax ALK Nordic 75 000 SQ-T
ILIT + Vitamin D
ILIT + placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis Due to Grass Pollen
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 Previous immunotherapy BMI > 35 house dust mite allergy with symptoms or allergy towards furry animals with exposition 25(OH)Vitamin D levels < 25 or > 75 nmol/L 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 medication with antiepileptic drugs, glykosides, orlistat, statines, thiazide diuretics Mb Paget, osteoporosis or sarcidosis Hyperparathyroidism or other disease conferring risk of hypercalcemia malabsorption or bowel disease with diarrea tendency for formation of kidney stones hereditary pseudohypoparathyroidism with decreased phosphorous secretion use of Vitamin D supplementation or excessive use of sun tanning booths drug abuse intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1 Mental incapacity to follow study protocol withdrawn consent other significant disease allergy towards study medication
Sites / Locations
- Skåne University Hospital, ENT department
- Karolinska University Hospital, ENT-departmentRecruiting
- Örebro University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
SLIT
ILIT + Vitamin D
ILIT + placebo
Arm Description
Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years
Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Outcomes
Primary Outcome Measures
CSMS
Daily Combined Symptoms and Medication Scores (0-3)
Secondary Outcome Measures
CSMS peak pollen season
Daily Combined Symptoms and Medication Scores (0-3) during the 15 consecutive days with the highest pollen count
RQLQ
Juniper Rhinoconjunctivitis Quality of Life Questionnaire, weekly scores (0-28)
VAS (0-10)
Recalled symptoms severity at visual analogue scale
Serolology with immunoglobulins
Total and grass specific levels of IgE, IgG, IgG4, IgA in serum
Full Information
NCT ID
NCT06061848
First Posted
September 11, 2023
Last Updated
September 25, 2023
Sponsor
Lars Olaf Cardell
1. Study Identification
Unique Protocol Identification Number
NCT06061848
Brief Title
Sublingual Immunotherapy Compared to Intralymphatic Immunotherapy With Concomitant Vitamin D, a Randomised Placebo Controlled Study
Acronym
ILIT vs SLIT
Official Title
Sublingual Immunotherapy Compared to Intralymphatic Immunotherapy With Concomitant Vitamin D, a Randomised Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 28, 2030 (Anticipated)
Study Completion Date
December 28, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Olaf Cardell
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis Due to Grass Pollen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SLIT
Arm Type
Active Comparator
Arm Description
Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years
Arm Title
ILIT + Vitamin D
Arm Type
Active Comparator
Arm Description
Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Arm Title
ILIT + placebo
Arm Type
Active Comparator
Arm Description
Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Intervention Type
Drug
Intervention Name(s)
SLIT Grazax ALK Nordic 75 000 SQ-T
Intervention Description
Daily sublingual grass allergen tablets
Intervention Type
Drug
Intervention Name(s)
ILIT + Vitamin D
Other Intervention Name(s)
Alutard SQ timothy and Vicotrat D3
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ILIT + placebo
Other Intervention Name(s)
Alutard SQ timothy and Sodium chloride
Intervention Description
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 Measure Information:
Title
CSMS
Description
Daily Combined Symptoms and Medication Scores (0-3)
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 Measure Information:
Title
CSMS peak pollen season
Description
Daily Combined Symptoms and Medication Scores (0-3) during the 15 consecutive days with the highest pollen count
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.
Title
RQLQ
Description
Juniper Rhinoconjunctivitis Quality of Life Questionnaire, weekly scores (0-28)
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.
Title
VAS (0-10)
Description
Recalled symptoms severity at visual analogue scale
Time Frame
4-6 months before treatment and 6-9 months after treatment
Title
Serolology with immunoglobulins
Description
Total and grass specific levels of IgE, IgG, IgG4, IgA in serum
Time Frame
1 year before treatment, 4-6 weeks after treatment, 1 year after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Previous immunotherapy
BMI > 35
house dust mite allergy with symptoms or allergy towards furry animals with exposition
25(OH)Vitamin D levels < 25 or > 75 nmol/L
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
medication with antiepileptic drugs, glykosides, orlistat, statines, thiazide diuretics
Mb Paget, osteoporosis or sarcidosis
Hyperparathyroidism or other disease conferring risk of hypercalcemia
malabsorption or bowel disease with diarrea
tendency for formation of kidney stones
hereditary pseudohypoparathyroidism with decreased phosphorous secretion
use of Vitamin D supplementation or excessive use of sun tanning booths
drug abuse
intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1
Mental incapacity to follow study protocol
withdrawn consent
other significant disease
allergy towards study medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agneta Karlsson, Study nurse
Phone
+46 72 580 29 63
Email
agneta.j.karlsson@regionstockholm.se
First Name & Middle Initial & Last Name or Official Title & Degree
Laila Hellkvist, MD, PhD
Phone
+46 72 469 46 07
Email
laila.hellkvist@regionstockholm.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars O Cardell, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital, ENT department
City
Lund
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franziska Nordström, MD
Email
franziska.nordstrom@skane.se
Facility Name
Karolinska University Hospital, ENT-department
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eirini Paziou, MD
Phone
+46 8 123 723 96
Email
eirini.paziou@regionstockholm.se
First Name & Middle Initial & Last Name & Degree
Laila Hellkvist, MD, PhD
Phone
+46 72 469 46 07
Email
laila.hellkvist@regionstockholm.se
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanj Saber, MD
Email
amanj.saber@regionorebrolan.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sublingual Immunotherapy Compared to Intralymphatic Immunotherapy With Concomitant Vitamin D, a Randomised Placebo Controlled Study
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