Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy
|ClinicalTrials.gov Identifier: NCT02679105|
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rhinitis, Allergic||Drug: ALK Alutard birch or 5-grasses Drug: ALK diluent||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U -a Human Randomized Clinical Trial|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||March 2019|
Placebo Comparator: ALK diluent
Drug: ALK diluent
0,3% human albumin
Other Name: Human albumin
Active Comparator: ALK Alutard birch or 5-grasses
Grass pollen suspension or birch pollen suspension
Drug: ALK Alutard birch or 5-grasses
3 injections with 4-5 weeks interval.
- Total daily symptoms and medications score [ Time Frame: 5-7 months after treatment ]Difference between active and placebo group in total daily symptoms and medications score during the pollen season.
- Improvement on Visual Analogue Scale (VAS) [ Time Frame: During pollen season and recalled after pollen season, approximately 1 year after the start of treatment. ]Difference in improvement on VAS between active and placebo group.
- Change in skin prick test reactivity [ Time Frame: 4-8 weeks after treatment, 9-12 months after treatment ]Tested with ALK Soluprick. Measured as the wheal area in millimeter for birch- or grass pollen.
- Change in symptoms score after nasal allergen challenge [ Time Frame: 4-8 weeks after treatment, 9-12 months after treatment ]0,1 ml of ALK Aquagen Birch or Timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded.
- Difference between active and placebo group in Quality of Life measured with Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: Up to 7 months after treatment. ]At peak pollen season after treatment.
- Difference between active and placebo group in Quality of Life measured with Sino Nasal Outcome Test -22 (SNOT-22) [ Time Frame: Up to 7 months after treatment. ]At peak pollen season after treatment.
- Change in allergen specific S- antibody levels. [ Time Frame: 4-8 weeks after treatment, 9-12 months after treatment ]IgE, IgG, IgG4
- Incidence of adverse events graded as mild-moderate-severe [ Time Frame: From first injection to 30 days after last injection. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679105
|Allergy Unit, Södra Älvsborgs Hospital|
|Borås, Sweden, 501 82|
|ENT department, Skånes University Hospital Malmö and Lund|
|Malmö, Sweden, 205 02|
|ENT department, Karolinska University Hospital|
|Stockholm, Sweden, 141 86|
|Principal Investigator:||Lars Olaf Cardell, Professor||Karolinska University Hospital|