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Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

This study has been terminated.
Information provided by:
Stallergenes Greer Identifier:
First received: December 12, 2006
Last updated: December 15, 2006
Last verified: December 2006
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.

Condition Intervention Phase
Allergy Biological: Subcutaneous immunotherapy - Recombinant birch pollen Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Further study details as provided by Stallergenes Greer:

Primary Outcome Measures:
  • Reduction of symptom and medication scores.

Estimated Enrollment: 160
Study Start Date: November 2002
Estimated Study Completion Date: November 2005

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00410930

Pr Gabrielle PAULI
Strasbourg, France, 67091
Sponsors and Collaborators
Stallergenes Greer
Principal Investigator: Gabrielle PAULI, MD, Pr Hôpital Liautey - Strasbourg, France
  More Information Identifier: NCT00410930     History of Changes
Other Study ID Numbers: DV08.01
Study First Received: December 12, 2006
Last Updated: December 15, 2006

Keywords provided by Stallergenes Greer:
Immunotherapy, major allergen, birch processed this record on September 21, 2017