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

Allergies Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719511
• Other study ID #: ZU-SkinSIT-002
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2008
• Last updated: February 16, 2011
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2011
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Evaluation of patch as specific immunotherapy in allergic patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergies

Intervention

Drug:
• Purified allergen dose 1 integrated in a Patch system
Epicutaneous application of a patch
• Purified allergen dose 2 integrated in a Patch system
Epicutaneous application of a patch
• Purified allergen dose 3 integrated in a Patch system
Epicutaneous application of a patch
• Purified allergen integrated in a Patch system
Epicutaneous application of a patch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes