Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
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
1 other identifier
interventional
132
1 country
1
Brief Summary
Evaluation of patch as specific immunotherapy in allergic patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 17, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 17, 2011
February 1, 2011
1.8 years
July 17, 2008
February 16, 2011
Conditions
Keywords
Outcome Measures
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
2010
Study Arms (4)
1
EXPERIMENTALPatch allergen dose 1
2
EXPERIMENTALPatch allergen dose 2
3
EXPERIMENTALPatch allergen dose 3
4
EXPERIMENTALPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Zurich, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
01 Studienregister MasterAdmins
UniversitaetsSpital Zuerich
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 17, 2008
First Posted
July 21, 2008
Study Start
February 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
February 17, 2011
Record last verified: 2011-02