A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy - Full Text View

Sponsors and Collaborators:	University of Zurich AlleCure
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00470457

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 II

MedlinePlus related topics: Allergy Hay Fever

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 National Clinical Trials Identifier (NCT ID):

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.

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

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Otorhinolaryngologic Diseases
Immune System Diseases
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate
Rhinitis
Nose Diseases
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009