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| Name | Class |
|---|---|
| Skane University Hospital | OTHER |
| Karolinska University Hospital | OTHER |
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The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
***IMPORTANT INFORMATION!*** The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.
40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralymphatic placebo injections | Placebo Comparator | ALK Diluent, ATC-code V07AB. 3 injections with 4-7 weeks interval. |
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| Intralymphatic active injections | Active Comparator | ATC-code V01AA02. 3 injections with 4-7 weeks interval in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U, 10000 SQ-U. ***IMPORTANT INFORMATION! The up-dosing protocol is changed due to an adverse event at the last injection. New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U. *** |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALK Diluent | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean combined daily symptoms-and-medications-score | Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids). | Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean total daily symptoms score | Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) | Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). |
| Mean total daily medications score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars-Olaf Cardell, Professor | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund | Lund | 221 85 | Sweden | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34379802 | Derived | Hellkvist L, Hjalmarsson E, Weinfeld D, Dahl A, Karlsson A, Westman M, Lundkvist K, Winqvist O, Georen SK, Westin U, Cardell LO. High-dose pollen intralymphatic immunotherapy: Two RDBPC trials question the benefit of dose increase. Allergy. 2022 Mar;77(3):883-896. doi: 10.1111/all.15042. Epub 2021 Aug 29. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D000485 | Allergens |
| ID | Term |
|---|---|
| D000941 | Antigens |
| D001685 | Biological Factors |
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| ALK Alutard SQ 5-grasses or ALK Alutard Birch |
| Drug |
Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension. |
|
|
Daily scoring of medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids). |
| Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). |
| Change in subjective allergic symptoms following nasal allergen provocation | The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation. | Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. |
| Effects on quality of life | Juniper Rhinitis quality of life questionnaire (RQLQ) questionnaires | During peak pollen season which will be up to 6 months after completed treatment. |
| Short term change of skin reactivity | Skin prick test | Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. |
| S-IgE Grass or Birch | Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment |
| S-IgG4 Grass or Birch | Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment |
| Registration of adverse event | From the first injection to 30 days after the last injections has been given |
| ENT-department, Karolinska University Hospital Huddinge (ENT-department B51) |
| Stockholm |
| 141 86 |
| Sweden |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |