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

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT00719511
Collaborator
(none)
132
Enrollment
1
Location
4
Arms
22
Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of patch as specific immunotherapy in allergic patients

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (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
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 [2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Zurich Switzerland

Sponsors and Collaborators

  • University of Zurich

Investigators

  • Study Director: 01 Studienregister MasterAdmins, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00719511
Other Study ID Numbers:
  • ZU-SkinSIT-002
First Posted:
Jul 21, 2008
Last Update Posted:
Feb 17, 2011
Last Verified:
Feb 1, 2011
Keywords provided by , ,
Rhinoconjunctivitis
Allergic

Study Results

No Results Posted as of Feb 17, 2011