Study to Asses Efficacy of Intralymphatic Immunotherapy (ILIT)
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|ClinicalTrials.gov Identifier: NCT01166269|
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : November 8, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Allergy||Biological: phleum pratense (grass-allergen) Biological: phleum pratense (grass allergen) Other: physiological saline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166269
|Dermato-allergological dept. K|
|Gentofte, Hellerup, Denmark, 2900|
|Principal Investigator:||Hans-Joergen Malling, Prof. Dr. Med.||Copenhagen University Hospital, Gentofte, Denmark|