Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

December 15, 2006 updated by: Stallergenes Greer

Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Pr Gabrielle PAULI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of symptom and medication scores.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stallergenes Greer

Investigators

  • Principal Investigator: Gabrielle PAULI, MD, Pr, Hôpital Liautey - Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

December 12, 2006

First Submitted That Met QC Criteria

December 12, 2006

First Posted (ESTIMATE)

December 13, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 19, 2006

Last Update Submitted That Met QC Criteria

December 15, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DV08.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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