Study to Assess the Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutanous Allergen Administration

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00457444
First received: April 5, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

Primary Objective Comparison of the inhibition of the allergic response assessed by nasal provocation test after epicutanous pollen allergen administration and placebo epicutaneous administration.

Secondary Objectives Comparison of the efficacy of the placebo with that of the epicutanous pollen allergen administration evaluated by visual analog symptom scales (nasal itching, sneezing, rhinorrhea, conjunctival redness, and lacrimation, lung symptoms ), Comparison of the inhibition of the allergic response assessed by skin prick test after epicutanous pollen allergen administration and placebo epicutaneous administration.

  • Trial with medicinal product

Condition Intervention Phase
Rhinoconjunctivitis
Drug: Pollen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ZU-SkinSIT-001 Single Center Phase I/IIa, Placebo Controlled, Randomized, Double Blind Study to Assess the Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutanous Allergen Administration

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • efficacy

Estimated Enrollment: 35
Study Start Date: December 2005
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 nasal provocation test

Exclusion criteria:

  • Atopic eczema in history or permanent
  • 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
  • Mastocytosis (cutaneous or systemic)
  • Significant cardiovascular disease
  • Hypertension (blood pressure > 160 / 95)
  • Significant pulmonary, renal and/or hepatic disease
  • Significant hematological disorder
  • Moderate or severe asthma
  • History of malignancy
  • History of neurological or psychatric disease
  • 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
    • Tricyclic antidepressants
    • Daily use of Beta-agonists or steroid inhalers
  • Participation in another clinical trial /study in between the last 60 days
  • Participation in another clinical trial / study at the moment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457444

Locations
Switzerland
University Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00457444     History of Changes
Other Study ID Numbers: ZU-SkinSIT-001
Study First Received: April 5, 2007
Last Updated: April 5, 2007
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014