Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis

This study has been completed.
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG Identifier:
First received: March 30, 2006
Last updated: March 8, 2013
Last verified: March 2013
Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

Condition Intervention Phase
Birch Pollen Allergy
Biological: Recombinant birch pollen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, Bet v 1

Further study details as provided by Allergopharma GmbH & Co. KG:

Study Start Date: December 2003
Study Completion Date: June 2009
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Positive Skin Prick Test reaction to birch pollen
  • Positive RAST result to birch pollen
  • Positive Provocation Test result to birch pollen

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies
  Contacts and Locations
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Please refer to this study by its identifier: NCT00309062

Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Principal Investigator: Annemie Narkus, M D
  More Information

Additional Information:
No publications provided

Responsible Party: Allergopharma GmbH & Co. KG Identifier: NCT00309062     History of Changes
Other Study ID Numbers: Al0103rB
Study First Received: March 30, 2006
Last Updated: March 8, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:
Birch pollen

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Rhinitis processed this record on November 30, 2015