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Study to Asses Efficacy of Intralymphatic Immunotherapy

NCT ID: NCT01166269

Last Updated: 2012-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Allergy

Keywords

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grass-pollen allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Grass-Allergen x 6

This arm will receive 6 injections of allergen.

Group Type EXPERIMENTAL

phleum pratense (grass-allergen)

Intervention Type BIOLOGICAL

6 injections of grass-allergen. Every dose will be 1000 SQ-U.

grass-allergen x 3 and placebo x 3

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

Group Type ACTIVE_COMPARATOR

phleum pratense (grass allergen)

Intervention Type BIOLOGICAL

3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)

placebo x 6

this arm will receive 6 injections of placebo.

Group Type PLACEBO_COMPARATOR

physiological saline

Intervention Type OTHER

6 injections of placebo (physiological saline)in a lymph node.

Interventions

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phleum pratense (grass-allergen)

6 injections of grass-allergen. Every dose will be 1000 SQ-U.

Intervention Type BIOLOGICAL

phleum pratense (grass allergen)

3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)

Intervention Type BIOLOGICAL

physiological saline

6 injections of placebo (physiological saline)in a lymph node.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TRYG Foundation

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Professor, Dr. Med Hans-Joergen Malling

Professor Dr. Med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans-Joergen Malling, Prof. Dr. Med.

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital, Gentofte, Denmark

Locations

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Dermato-allergological dept. K

Gentofte Municipality, Hellerup, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ILIT

Identifier Type: -

Identifier Source: org_study_id