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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00719511
Enrollment
132
Registered
2008-07-21
Start date
2008-02-29
Completion date
2009-12-31
Last updated
2011-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergies

Keywords

Rhinoconjunctivitis, Allergic

Brief summary

Evaluation of patch as specific immunotherapy in allergic patients

Interventions

DRUGPurified allergen dose 1 integrated in a Patch system

Epicutaneous application of a patch

DRUGPurified allergen dose 2 integrated in a Patch system

Epicutaneous application of a patch

DRUGPurified allergen dose 3 integrated in a Patch system

Epicutaneous application of a patch

DRUGPurified allergen integrated in a Patch system

Epicutaneous application of a patch

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
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 treatment2010

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026