Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.
Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed.
Objective: To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass.
Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active ILIT treated | Active Comparator | Patients that have received ILIT with birch and grass allergen 5-6 years previously |
|
| Non- AIT treated | Placebo Comparator | Patients that have received placebo ILIT 5-6 years previously and patients with birch and grass pollen induced allergic rhinitis that have not previously been treated with allergen immunotherapy (AIT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALK Alutard 5-grasses and birch | Drug | Intralymphatic injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal grass allergen provocation | The symptoms are recorded during 30 minutes after nasal spray with grass allergen | 5-6 years after active or placebo ILIT |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal birch allergen provocation | The symptoms are recorded during 30 minutes after nasal spray with grass allergen | 5-6 years after active or placebo ILIT |
| Combined symptoms and medciations score |
Not provided
Inclusion Criteria:
- Moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific IgE antibodies
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|
| 29908212 | Background | Hellkvist L, Hjalmarsson E, Kumlien Georen S, Karlsson A, Lundkvist K, Winqvist O, Westin U, Cardell LO. Intralymphatic immunotherapy with 2 concomitant allergens, birch and grass: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2018 Oct;142(4):1338-1341.e9. doi: 10.1016/j.jaci.2018.05.030. Epub 2018 Jun 13. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ALK Diluent | Drug | intralymphatic injections |
|
|
Ranging from 0- no symptoms and medication, to 6- maximum symptoms and medication.
| Pollen season 5-7 years after active or placebo ILIT |
| Rhinoconjunctivitis quality of life questionnaire | Average score of 28 questions ranging from 0-no impairment of quality of life, to 6- maximum impairment of quality of life. | Pollen season 5-7 years after active or placebo ILIT |
| Sinonasal outcome test quality of life questionnaire | Sum of 22 questions. The score ranges from 0-no impairment of quality of life, to 110- maximum impairment of quality of life. | Pollen season 5-7 years after active or placebo ILIT |
| Allergen specific IgE | Blood test | 5-6 years after active or placebo ILIT |
| Allergen specific IgG4 | Blood test | 5-6 years after active or placebo ILIT |
| T-cell and basophil activation | Blood samples and lymph node aspirates are investigated with flow cytometry | 5-6 years after active or placebo ILIT |
| Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö |
| Malmö |
| 20502 |
| Sweden |
| ENT department, Karolinska University Hospital | Stockholm | 141 86 | Sweden |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |