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

February 16, 2011 updated by: University of Zurich

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZU-SkinSIT-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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