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

NCT00457444 | Completed Phase 1

• 1 other identifier: ZU-SkinSIT-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• efficacy

Interventions

Pollen DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 nasal provocation test

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Interventions

Propolis

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 6, 2007
• Study Start: December 1, 2005
• Study Completion: November 1, 2006
• Last Updated: April 6, 2007

Record last verified: 2007-04

Locations

CH (1)