Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration - Full Text View

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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 ]


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)
Sexes Eligible for Study:	All
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

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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

Keywords provided by University of Zurich:


Rhinoconjunctivitis Allergic

ClinicalTrials.gov processed this record on June 22, 2017