Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration

Study Overview
=================
Brief Summary
-----------------
Evaluation of patch as specific immunotherapy in allergic patients

Official Title
-----------------
Single Center Phase I/IIa, Placebo Controlled, Randomized, Double-blind, Dose-response Study to Assess the Optimal Dose as Well as Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration

Conditions
-----------------
Allergies

Intervention / Treatment
-----------------
* Drug: Purified allergen dose 1 integrated in a Patch system
* Drug: Purified allergen dose 2 integrated in a Patch system
* Drug: Purified allergen dose 3 integrated in a Patch system
* Drug: Purified allergen integrated in a Patch system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Written informed consent History of grass pollen allergic rhinitis 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 allergic rhinitis Symptoms of infectious disease with rhinitis in between the last 2 weeks 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 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 History of neurological or psychiatric disease History of autoimmune disease Antihistamines with longed half-lives in the last week Systemic or topical steroids for 5 days Active infectious disease 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patch allergen dose 1 | Drug: Purified allergen dose 1 integrated in a Patch system<br>* Epicutaneous application of a patch<br>|
| Experimental: 2<br>Patch allergen dose 2 | Drug: Purified allergen dose 2 integrated in a Patch system<br>* Epicutaneous application of a patch<br>|
| Experimental: 3<br>Patch allergen dose 3 | Drug: Purified allergen dose 3 integrated in a Patch system<br>* Epicutaneous application of a patch<br>|
| Experimental: 4<br>Placebo | Drug: Purified allergen integrated in a Patch system<br>* Epicutaneous application of a patch<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the efficacy of the placebo with that of three different test doses of the epicutaneous pollen allergen administration evaluated by visual analog scales after the treatment |  | 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhinoconjunctivitis, Allergic