Status:
COMPLETED
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
Lead Sponsor:
University of Zurich
Conditions:
Allergies
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Evaluation of patch as specific immunotherapy in allergic patients
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00719511
Start Date
February 1 2008
End Date
December 1 2009
Last Update
February 17 2011
Active Locations (1)
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1
Zurich, Switzerland