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

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

Evaluation of patch as specific immunotherapy in allergic patients

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