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

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

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Key information

Conditions

Rhinoconjunctivitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Zurich

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 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

Treatment and study plan

Pollen

Drug

Primary outcomes

efficacy

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Important dates

Study start: 2005
Study completion: 2006
First posted: Apr 6, 2007
Registry last updated: Apr 6, 2007

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.

Published trials that share one or more normalized conditions with this study.

Completed