Study to Assess the Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutanous Allergen Administration

Study Overview
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Brief Summary
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Primary Objective Comparison of the inhibition of the allergic response assessed by nasal provocation test after epicutanous pollen allergen administration and placebo epicutaneous administration. Secondary Objectives Comparison of the efficacy of the placebo with that of the epicutanous pollen allergen administration evaluated by visual analog symptom scales (nasal itching, sneezing, rhinorrhea, conjunctival redness, and lacrimation, lung symptoms ), Comparison of the inhibition of the allergic response assessed by skin prick test after epicutanous pollen allergen administration and placebo epicutaneous administration. Trial with medicinal product

Official Title
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ZU-SkinSIT-001 Single Center Phase I/IIa, Placebo Controlled, Randomized, Double Blind Study to Assess the Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutanous Allergen Administration

Conditions
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Rhinoconjunctivitis

Intervention / Treatment
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* Drug: Pollen


Participation Criteria
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Eligibility Criteria
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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 nasal provocation test Exclusion criteria: Atopic eczema in history or permanent 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 Mastocytosis (cutaneous or systemic) Significant cardiovascular disease Hypertension (blood pressure > 160 / 95) Significant pulmonary, renal and/or hepatic disease Significant hematological disorder Moderate or severe asthma History of malignancy History of neurological or psychatric disease 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 Tricyclic antidepressants Daily use of Beta-agonists or steroid inhalers Participation in another clinical trial /study in between the last 60 days Participation in another clinical trial / study at the moment

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pollen|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  |  |