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

This study has been completed.
Sponsor:
Collaborator:
AlleCure
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00470457
First received: May 4, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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 (cumulative allergen dose 3â 000 units) are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years (cumulative allergen dose 4â 031â 540 units).

  • 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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Allergy Hay Fever
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470457

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

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00470457     History of Changes
Other Study ID Numbers: ZU-GTP-001
Study First Received: May 4, 2007
Last Updated: May 4, 2007
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity
Conjunctivitis
Rhinitis
Nose Diseases
Respiratory Tract Diseases
 Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013