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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
Sponsor:
Information provided by:
University of Zurich

Study Description
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Brief Summary:
Evaluation of patch as specific immunotherapy in allergic patients

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 Design
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
More Information
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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