NCT00777374

Brief Summary

Seasonal rhinoconjunctivitis or hay fever is a common atopic condition that is frequently seen in clinical practice. Grass pollen is the major cause of pollinosis in many parts of the world. Immunotherapy is the only treatment that may affect the natural course of allergic diseases, and it may also prevent the development of asthma in patients with allergic rhinitis. With conventional subcutaneous desensitization the duration of treatment is around 3-5 years and usually comprises around 30-100 allergen injections. As high allergen doses have to be injected, allergic side effects may occur and patients must stay under medical supervision for at least 1 hour. Transcutaneous immunization (TCI) is a needle -free technique that delivers antigens and adjuvants to potent epicutaneous immune cells. The aim of the new epicutaneous route of desensitization is to more specifically target the immune system by loading Langerhans cells with the allergen. Lower antigen doses can be applied, such that side effects are reduced.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

Enrollment Period

2.1 years

First QC Date

October 21, 2008

Last Update Submit

January 31, 2011

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Comparison of the efficacy of the placebo patch with the allergen patch with combined symptom medication score

    2009 - 2011

Study Arms (2)

1

EXPERIMENTAL

Allergen containing patch

Drug: Patch

2

PLACEBO COMPARATOR

Placebo patch

Drug: Placebo patch

Interventions

PatchDRUG

epicutaneous application of allergen patch

1
Placebo patchDRUG

epicutanoeus application of a placebo patch

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Interventions

Transdermal Patch

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

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

October 21, 2008

First Posted

October 22, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 1, 2011

Record last verified: 2011-01

Locations

CH(1)