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Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects With Epicutanoeus Allergen Administration (ZU-SkinSIT-003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00777374
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : February 1, 2011
Information provided by:
University of Zurich

Brief Summary:
Seasonal rhinoconjunctivitis or hay fever is a common atopic condition that is frequently seen in clinical practice. Grass pollen is the major cause of pollinosis in many parts of the world. Immunotherapy is the only treatment that may affect the natural course of allergic diseases, and it may also prevent the development of asthma in patients with allergic rhinitis. With conventional subcutaneous desensitization the duration of treatment is around 3-5 years and usually comprises around 30-100 allergen injections. As high allergen doses have to be injected, allergic side effects may occur and patients must stay under medical supervision for at least 1 hour. Transcutaneous immunization (TCI) is a needle -free technique that delivers antigens and adjuvants to potent epicutaneous immune cells. The aim of the new epicutaneous route of desensitization is to more specifically target the immune system by loading Langerhans cells with the allergen. Lower antigen doses can be applied, such that side effects are reduced.

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Drug: Patch Drug: Placebo patch Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Center Phase I/IIa, Placebo Controlled, Randomized, Double-blind Preseasonal Study to Assess Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
Study Start Date : October 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: 1
Allergen containing patch
Drug: Patch
epicutaneous application of allergen patch

Placebo Comparator: 2
Placebo patch
Drug: Placebo patch
epicutanoeus application of a placebo patch

Primary Outcome Measures :
  1. Comparison of the efficacy of the placebo patch with the allergen patch with combined symptom medication score [ Time Frame: 2009 - 2011 ]

Information from the National Library of Medicine

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

Inclusion criteria: Written informed consent History of grass pollen allergic rhinitis for at least two years Male and female between 18 years to 65 years Positive skin-prick test to grass pollen Positive conjunctival provocation test

Exclusion criteria: Eczematous skin lesions on the upper arms Perennial rhinitis due to perennial allergies or anatomical reason (polyps, septal deviation) Symptoms of infectious disease with rhinitis in between the last week Surgical intervention in between the last 30 days Pregnancy or nursing History of HIV or AIDS History of mastocytosis (cutaneous or systemic) History of significant cardiovascular disease Uncontrolled Hypertension (blood pressure > 160 / 95) History of significant pulmonary, renal and/or hepatic disease History of significant hematological disorder Moderate or severe asthma History of malignancy Significant neurological or psychatric disease History of active autoimmune disease Antihistamines with longed half-lives in the last week Systemic or topical steroids for 5 days Depot corticosteroids for the last two months Active infectious disease Adipositas per magna

Contraindicated medications:

  • immunosuppressive agents
  • Betablockers
  • ACE-inhibitors, AT 2 Antagonists
  • tricyclic antidepressants
  • daily use of Beta-agonists or steroid inhalers
  • Participation in another clinical trial /study at the moment or within the last 60 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00777374

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Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
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Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
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Responsible Party: PD Dr. Thomas Kündig, University of Zurich Identifier: NCT00777374    
Other Study ID Numbers: ZU-SkinSIT-003
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011