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Study to Asses Efficacy of Intralymphatic Immunotherapy (ILIT)

Primary Purpose

Allergy

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
phleum pratense (grass-allergen)
phleum pratense (grass allergen)
physiological saline
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy focused on measuring grass-pollen allergy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • grass pollen allergy through at least 2 seasons
  • positive skin prick test
  • positive Specific IgE of at least 2. (CAP)
  • Signed informed consent
  • for females a negative pregnancy test.

Exclusion Criteria:

  • out of age limits
  • rhinoconjunctivitis all year round.
  • uncontrolled seasonal asthma
  • patients treated with steroids continuously or beta-blockers.
  • pregnancy and breastfeeding
  • HIV, Hepatitis B+c, and other immunological diseases.
  • psychiatric disease
  • treatment with SCIT or SLIT within the last 5 years
  • participation in other clinical trials within the last 3 months.

Sites / Locations

  • Dermato-allergological dept. K

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Grass-Allergen x 6

grass-allergen x 3 and placebo x 3

placebo x 6

Arm Description

This arm will receive 6 injections of allergen.

this arm will receive 3 injections of allergen, and 3 injections of placebo.

this arm will receive 6 injections of placebo.

Outcomes

Primary Outcome Measures

symptom improvement
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.

Secondary Outcome Measures

Improvement of reactivity of skin prick test and Specific IgE

Full Information

First Posted
July 20, 2010
Last Updated
November 7, 2012
Sponsor
Rigshospitalet, Denmark
Collaborators
TRYG Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01166269
Brief Title
Study to Asses Efficacy of Intralymphatic Immunotherapy
Acronym
ILIT
Official Title
Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
TRYG Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
grass-pollen allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grass-Allergen x 6
Arm Type
Experimental
Arm Description
This arm will receive 6 injections of allergen.
Arm Title
grass-allergen x 3 and placebo x 3
Arm Type
Active Comparator
Arm Description
this arm will receive 3 injections of allergen, and 3 injections of placebo.
Arm Title
placebo x 6
Arm Type
Placebo Comparator
Arm Description
this arm will receive 6 injections of placebo.
Intervention Type
Biological
Intervention Name(s)
phleum pratense (grass-allergen)
Intervention Description
6 injections of grass-allergen. Every dose will be 1000 SQ-U.
Intervention Type
Biological
Intervention Name(s)
phleum pratense (grass allergen)
Intervention Description
3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)
Intervention Type
Other
Intervention Name(s)
physiological saline
Intervention Description
6 injections of placebo (physiological saline)in a lymph node.
Primary Outcome Measure Information:
Title
symptom improvement
Description
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.
Time Frame
2 seasons. (2 years)
Secondary Outcome Measure Information:
Title
Improvement of reactivity of skin prick test and Specific IgE
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: grass pollen allergy through at least 2 seasons positive skin prick test positive Specific IgE of at least 2. (CAP) Signed informed consent for females a negative pregnancy test. Exclusion Criteria: out of age limits rhinoconjunctivitis all year round. uncontrolled seasonal asthma patients treated with steroids continuously or beta-blockers. pregnancy and breastfeeding HIV, Hepatitis B+c, and other immunological diseases. psychiatric disease treatment with SCIT or SLIT within the last 5 years participation in other clinical trials within the last 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Joergen Malling, Prof. Dr. Med.
Organizational Affiliation
Copenhagen University Hospital, Gentofte, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermato-allergological dept. K
City
Gentofte
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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Study to Asses Efficacy of Intralymphatic Immunotherapy

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