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

May 4, 2007
May 4, 2007
June 2001
Not Provided
Safety efficacy and toxicity [ Time Frame: 3 years ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy
A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy in Grass and/or Tree Pollen Allergic Subjects by Intralymphatic Allergen Administration

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rhinoconjunctivitis Due to Grass Pollen Allergy
Biological: Allergen specific immunotherapy
Not Provided
Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wüthrich B, Crameri R, Graf N, Johansen P, Kündig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. Epub 2008 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
March 2005
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00470457
ZU-GTP-001
No
Not Provided
University of Zurich
AlleCure
Study Director: Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP