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

This study has been completed.
Information provided by:
University of Zurich Identifier:
First received: May 4, 2007
Last updated: December 2, 2015
Last verified: December 2015

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

Condition Intervention Phase
Rhinoconjunctivitis Due to Grass Pollen Allergy Biological: Allergen specific immunotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy in Grass and/or Tree Pollen Allergic Subjects by Intralymphatic Allergen Administration

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Safety efficacy and toxicity [ Time Frame: 3 years ]

Enrollment: 156
Study Start Date: June 2001
Study Completion Date: March 2005

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Written informed consent
  • History of allergic rhino-conjunctivitis in spring and summer
  • Age 18 years to 65 years
  • Positive skin prick test to grass pollen

Exclusion criteria:

  • Blood donation within previous 30 days
  • Surgery within the previous 30 days
  • Use of investigational drugs within previous 90 days
  • Pregnancy or nursing
  • Mastocytosis
  • Significant cardiovascular disease
  • Hypertension
  • Active infectious disease
  • Significant hepatic disease
  • Significant renal disease
  • Significant hematological disorder
  • Significant pulmonary disease
  • Moderate or severe asthma
  • Autoimmune disease
  • History of malignancy.
  • Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.
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Please refer to this study by its identifier: NCT00470457

Clinic for Dermatology University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Study Director: Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00470457     History of Changes
Other Study ID Numbers: ZU-GTP-001
Study First Received: May 4, 2007
Last Updated: December 2, 2015

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases processed this record on August 16, 2017