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

Rhinoconjunctivitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457444
• Other study ID #: ZU-SkinSIT-001
• Status: Completed
• Phase: Phase 1
• First received: April 5, 2007
• Last updated: April 5, 2007
• Start date: December 2005
• Est. completion date: November 2006

Study information

• Verified date: April 2007
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2006
• 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinoconjunctivitis

Intervention

Drug:
• Pollen

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy