Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
NCT ID: NCT00719511
Last Updated: 2011-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
132 participants
INTERVENTIONAL
2008-02-29
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Patch allergen dose 1
Purified allergen dose 1 integrated in a Patch system
Epicutaneous application of a patch
2
Patch allergen dose 2
Purified allergen dose 2 integrated in a Patch system
Epicutaneous application of a patch
3
Patch allergen dose 3
Purified allergen dose 3 integrated in a Patch system
Epicutaneous application of a patch
4
Placebo
Purified allergen integrated in a Patch system
Epicutaneous application of a patch
Interventions
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Purified allergen dose 1 integrated in a Patch system
Epicutaneous application of a patch
Purified allergen dose 2 integrated in a Patch system
Epicutaneous application of a patch
Purified allergen dose 3 integrated in a Patch system
Epicutaneous application of a patch
Purified allergen integrated in a Patch system
Epicutaneous application of a patch
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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University Hospital Zurich
Principal Investigators
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01 Studienregister MasterAdmins
Role: STUDY_DIRECTOR
UniversitaetsSpital Zuerich
Locations
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Zurich, , Switzerland
Countries
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Other Identifiers
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ZU-SkinSIT-002
Identifier Type: -
Identifier Source: org_study_id
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