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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinoconjunctivitis
• Intervention / Treatment: Drug: Patch; Drug: Placebo patch

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of the efficacy of the placebo patch with the allergen patch with combined symptom medication score	2009 - 2011

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (Estimate): October 22, 2008

Study Record Updates

• Last Update Posted (Estimate): February 1, 2011
• Last Update Submitted That Met QC Criteria: January 31, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: ZU-SkinSIT-003