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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
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
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

No publications provided

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 May 19, 2013