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

University of Zurich (UZH)

Status and phase: Completed; Phase 2

Conditions: Allergies

Treatments: Drug: Purified allergen integrated in a Patch system; Drug: Purified allergen dose 1 integrated in a Patch system; Drug: Purified allergen dose 3 integrated in a Patch system; Drug: Purified allergen dose 2 integrated in a Patch system

Study type: Interventional

Funder types: Other

Identifiers

NCT00719511

ZU-SkinSIT-002

Details and patient eligibility

About

Evaluation of patch as specific immunotherapy in allergic patients

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups

1

Experimental group

Description:

Patch allergen dose 1

Treatment:

Drug: Purified allergen dose 1 integrated in a Patch system

2

Experimental group

Description:

Patch allergen dose 2

Treatment:

Drug: Purified allergen dose 2 integrated in a Patch system

3

Experimental group

Description:

Patch allergen dose 3

Treatment:

Drug: Purified allergen dose 3 integrated in a Patch system

4

Experimental group

Description:

Placebo

Treatment:

Drug: Purified allergen integrated in a Patch system