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

Tracking Information

First Received Date ^ICMJE

July 17, 2008

Last Updated Date

February 16, 2011

Start Date ^ICMJE

February 2008

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00719511 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

Evaluation of patch as specific immunotherapy in allergic patients

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Allergies

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

132

Completion Date

December 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00719511

Other Study ID Numbers ^ICMJE

ZU-SkinSIT-002

Has Data Monitoring Committee

Responsible Party

PD Dr. Thomas Kündig, University Hospital Zurich

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

01 Studienregister MasterAdmins

UniversitaetsSpital Zuerich

Information Provided By

University of Zurich

Verification Date

February 2011

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

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