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

NCT ID: NCT00719511

Last Updated: 2011-02-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

Brief Summary

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Evaluation of patch as specific immunotherapy in allergic patients

Detailed Description

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Conditions

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Allergies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Patch allergen dose 1

Group Type EXPERIMENTAL

Purified allergen dose 1 integrated in a Patch system

Intervention Type DRUG

Epicutaneous application of a patch

2

Patch allergen dose 2

Group Type EXPERIMENTAL

Purified allergen dose 2 integrated in a Patch system

Intervention Type DRUG

Epicutaneous application of a patch

3

Patch allergen dose 3

Group Type EXPERIMENTAL

Purified allergen dose 3 integrated in a Patch system

Intervention Type DRUG

Epicutaneous application of a patch

4

Placebo

Group Type EXPERIMENTAL

Purified allergen integrated in a Patch system

Intervention Type DRUG

Epicutaneous application of a patch

Interventions

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Purified allergen dose 1 integrated in a Patch system

Epicutaneous application of a patch

Intervention Type DRUG

Purified allergen dose 2 integrated in a Patch system

Epicutaneous application of a patch

Intervention Type DRUG

Purified allergen dose 3 integrated in a Patch system

Epicutaneous application of a patch

Intervention Type DRUG

Purified allergen integrated in a Patch system

Epicutaneous application of a patch

Intervention Type DRUG

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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

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

Site Status

Countries

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Switzerland

Other Identifiers

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ZU-SkinSIT-002

Identifier Type: -

Identifier Source: org_study_id

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