Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
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ClinicalTrials.gov Identifier: NCT00719511 |
Recruitment Status
:
Completed
First Posted
: July 21, 2008
Last Update Posted
: February 17, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergies | Drug: Purified allergen dose 1 integrated in a Patch system Drug: Purified allergen dose 2 integrated in a Patch system Drug: Purified allergen dose 3 integrated in a Patch system Drug: Purified allergen integrated in a Patch system | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 132 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | December 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Patch allergen dose 1
|
Drug: Purified allergen dose 1 integrated in a Patch system
Epicutaneous application of a patch
|
Experimental: 2
Patch allergen dose 2
|
Drug: Purified allergen dose 2 integrated in a Patch system
Epicutaneous application of a patch
|
Experimental: 3
Patch allergen dose 3
|
Drug: Purified allergen dose 3 integrated in a Patch system
Epicutaneous application of a patch
|
Experimental: 4
Placebo
|
Drug: Purified allergen integrated in a Patch system
Epicutaneous application of a patch
|
- Comparison of the efficacy of the placebo with that of three different test doses of the epicutaneous pollen allergen administration evaluated by visual analog scales after the treatment [ Time Frame: 2010 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719511
Switzerland | |
Zurich, Switzerland |
Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
Responsible Party: | PD Dr. Thomas Kündig, University Hospital Zurich |
ClinicalTrials.gov Identifier: | NCT00719511 History of Changes |
Other Study ID Numbers: |
ZU-SkinSIT-002 |
First Posted: | July 21, 2008 Key Record Dates |
Last Update Posted: | February 17, 2011 |
Last Verified: | February 2011 |
Keywords provided by University of Zurich:
Rhinoconjunctivitis Allergic |