Study to Asses Efficacy of Intralymphatic Immunotherapy (ILIT)
The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm.
The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).
The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary.
The patients will be divided into three groups using allocation:
1 group with 6 injections of allergen
1 group with 3 injections of allergen and 3 injections of placebo
1 group with 6 injections of placebo. The trial will be double blinded.
|Allergy||Biological: phleum pratense (grass-allergen) Biological: phleum pratense (grass allergen) Other: physiological saline||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects|
- symptom improvement [ Time Frame: 2 seasons. (2 years) ]The patients will fill out a diary during the grasspollen-season before and after treatment. Also they will fill out a form for the general status of the season passed.
- Improvement of reactivity of skin prick test and Specific IgE [ Time Frame: 2 years ]
|Study Start Date:||July 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Grass-Allergen x 6
This arm will receive 6 injections of allergen.
Biological: phleum pratense (grass-allergen)
6 injections of grass-allergen. Every dose will be 1000 SQ-U.
Active Comparator: grass-allergen x 3 and placebo x 3
this arm will receive 3 injections of allergen, and 3 injections of placebo.
Biological: phleum pratense (grass allergen)
3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)
Placebo Comparator: placebo x 6
this arm will receive 6 injections of placebo.
Other: physiological saline
6 injections of placebo (physiological saline)in a lymph node.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166269
|Dermato-allergological dept. K|
|Gentofte, Hellerup, Denmark, 2900|
|Principal Investigator:||Hans-Joergen Malling, Prof. Dr. Med.||Copenhagen University Hospital, Gentofte, Denmark|