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OpenTrials
Completed

NCT Number: NCT00719511

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

Evaluation of patch as specific immunotherapy in allergic patients

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Key information

Conditions

Allergies Hypersensitivity Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Purified allergen dose 1 integrated in a Patch system

Drug

Epicutaneous application of a patch

Purified allergen dose 2 integrated in a Patch system

Drug

Epicutaneous application of a patch

Purified allergen dose 3 integrated in a Patch system

Drug

Epicutaneous application of a patch

Purified allergen integrated in a Patch system

Drug

Epicutaneous application of a patch

Primary outcomes

  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

    Time frame: 2010

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 21, 2008
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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