NCT00410930

Brief Summary

To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
Last Updated

December 19, 2006

Status Verified

December 1, 2006

First QC Date

December 12, 2006

Last Update Submit

December 15, 2006

Conditions

Allergy

Keywords

Immunotherapy, major allergen, birch

Outcome Measures

Primary Outcomes (1)

  • Reduction of symptom and medication scores.

Interventions

Subcutaneous immunotherapy - Recombinant birch pollenBIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA.
  • Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen)
  • Compliant patients
  • Written consent.

You may not qualify if:

  • Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium
  • Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.
  • Patients treated with beta-blockers or under continuous oral corticosteroids.
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pr Gabrielle PAULI

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Gabrielle PAULI, MD, Pr

    Hôpital Liautey - Strasbourg, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 13, 2006

Study Start

November 1, 2002

Study Completion

November 1, 2005

Last Updated

December 19, 2006

Record last verified: 2006-12

Locations

FR(1)