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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00719511
First received: July 17, 2008
Last updated: February 16, 2011
Last verified: February 2011
History of Changes
  Purpose
Evaluation of patch as specific immunotherapy in allergic patients

Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 132
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719511

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

Responsible Party: PD Dr. Thomas Kündig, University Hospital Zurich
ClinicalTrials.gov Identifier: NCT00719511     History of Changes
Other Study ID Numbers: ZU-SkinSIT-002 
Study First Received: July 17, 2008
Last Updated: February 16, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Rhinoconjunctivitis
Allergic

ClinicalTrials.gov processed this record on September 29, 2016