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
| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Skane University Hospital | OTHER |
| Sodra Alvsborgs Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALK diluent | Placebo Comparator | Human albumin |
|
| ALK Alutard birch or 5-grasses | Active Comparator | Grass pollen suspension or birch pollen suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALK Alutard birch or 5-grasses | Drug | 3 injections with 4-5 weeks interval. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total daily symptoms and medications score | Difference between active and placebo group in total daily symptoms and medications score during the pollen season. | 5-7 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement on Visual Analogue Scale (VAS) | Difference in improvement on VAS between active and placebo group. | During pollen season and recalled after pollen season, approximately 1 year after the start of treatment. |
| Change in skin prick test reactivity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lars Olaf Cardell, Professor | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy Unit, Södra Älvsborgs Hospital | Borås | 501 82 | Sweden | |||
| ENT department, Skånes University Hospital Malmö and Lund |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19001265 | Result | Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10. | |
| 23374268 |
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
| ALK diluent | Drug | 0,3% human albumin |
|
|
Tested with ALK Soluprick. Measured as the wheal area in millimeter for birch- or grass pollen. |
| 4-8 weeks after treatment, 9-12 months after treatment |
| Change in symptoms score after nasal allergen challenge | 0,1 ml of ALK Aquagen Birch or Timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded. | 4-8 weeks after treatment, 9-12 months after treatment |
| Difference between active and placebo group in Quality of Life measured with Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | At peak pollen season after treatment. | Up to 7 months after treatment. |
| Difference between active and placebo group in Quality of Life measured with Sino Nasal Outcome Test -22 (SNOT-22) | At peak pollen season after treatment. | Up to 7 months after treatment. |
| Change in allergen specific S- antibody levels. | IgE, IgG, IgG4 | 4-8 weeks after treatment, 9-12 months after treatment |
| Incidence of adverse events graded as mild-moderate-severe | From first injection to 30 days after last injection. |
| Malmö |
| 205 02 |
| Sweden |
| ENT department, Karolinska University Hospital | Stockholm | 141 86 | Sweden |
| Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056. |
| 24035151 | Result | Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013 Nov;132(5):1248-1252.e5. doi: 10.1016/j.jaci.2013.07.033. Epub 2013 Sep 13. No abstract available. |
| 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. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |