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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLIT | Active Comparator | Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years |
|
| ILIT + Vitamin D | Active Comparator | Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U. |
|
| ILIT + placebo | Active Comparator | Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLIT Grazax ALK Nordic 75 000 SQ-T | Drug | Daily sublingual grass allergen tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CSMS | Daily Combined Symptoms and Medication Scores (0-3) | 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 | Description | Time Frame |
|---|---|---|
| CSMS peak pollen season | Daily Combined Symptoms and Medication Scores (0-3) during the 15 consecutive days with the highest pollen count | 15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment. |
| RQLQ |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria only for ILIT group (due to vitamin D treatment)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agneta Karlsson, Study nurse | Contact | +46 72 580 29 63 | agneta.j.karlsson@regionstockholm.se | |
| Laila Hellkvist, MD, PhD | Contact | +46 72 469 46 07 | laila.hellkvist@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Lars O Cardell, Professor | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital, ENT department | Not yet recruiting | Lund | Sweden |
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| ILIT + Vitamin D |
| Drug |
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 |
|
|
| ILIT + placebo | Drug | 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 |
|
|
Juniper Rhinoconjunctivitis Quality of Life Questionnaire, weekly scores (0-28) |
| 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) | Recalled symptoms severity at visual analogue scale | 4-6 months before treatment and 6-9 months after treatment |
| Serolology with immunoglobulins | Total and grass specific levels of IgE, IgG, IgG4, IgA in serum | 1 year before treatment, 4-6 weeks after treatment, 1 year after treatment |
| Örebro University Hospital | Not yet recruiting | Örebro | Sweden |
|
| Karolinska University Hospital, ENT-department | Recruiting | Stockholm | Sweden |
|
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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