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

July 17, 2008
February 16, 2011
February 2008
November 2009   (final data collection date for primary outcome measure)
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 ]
Comparision 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 ]
Complete list of historical versions of study NCT00719511 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
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

Evaluation of patch as specific immunotherapy in allergic patients

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergies
  • Drug: Purified allergen dose 1 integrated in a Patch system
    Epicutaneous application of a patch
  • Drug: Purified allergen dose 2 integrated in a Patch system
    Epicutaneous application of a patch
  • Drug: Purified allergen dose 3 integrated in a Patch system
    Epicutaneous application of a patch
  • Drug: Purified allergen integrated in a Patch system
    Epicutaneous application of a patch
  • Experimental: 1
    Patch allergen dose 1
    Intervention: Drug: Purified allergen dose 1 integrated in a Patch system
  • Experimental: 2
    Patch allergen dose 2
    Intervention: Drug: Purified allergen dose 2 integrated in a Patch system
  • Experimental: 3
    Patch allergen dose 3
    Intervention: Drug: Purified allergen dose 3 integrated in a Patch system
  • Experimental: 4
    Placebo
    Intervention: Drug: Purified allergen integrated in a Patch system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
December 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00719511
ZU-SkinSIT-002
No
PD Dr. Thomas Kündig, University Hospital Zurich
University of Zurich
Not Provided
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP