Study to Asses Efficacy of Intralymphatic Immunotherapy

Allergy Clinical Trial

— ILIT  

Official title:

Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166269
• Other study ID #: ILIT
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 20, 2010
• Last updated: November 7, 2012
• Start date: July 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark:Copenhagen university hospital GCP-unit
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• phleum pratense (grass-allergen)
6 injections of grass-allergen. Every dose will be 1000 SQ-U.
• phleum pratense (grass allergen)
3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)

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

Locations

Country	Name	City	State
Denmark	Dermato-allergological dept. K	Gentofte	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 seasons. (2 years)	Yes
Secondary	Improvement of reactivity of skin prick test and Specific IgE		2 years	Yes