A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy

Phase 2

Completed

• Conditions: Rhinoconjunctivitis Due to Grass Pollen Allergy

• Registration Number: NCT00470457
• Lead Sponsor: University of Zurich

Brief Summary

Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated allergies. The disadvantages of SIT, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years.

* Trial with immunodulatory product / biological

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Study Completion: 2005-03
• Study First Submitted: 2007-05-04
• Study First Submitted QC: 2007-05-04
• Study First Posted: 2007-05-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety efficacy and toxicity	3 years

Trial Locations

Locations (1)

Clinic for Dermatology University Hospital of Zurich; 🇨🇭 Zurich, Switzerland