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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00309062
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : March 11, 2013
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG

Brief Summary:
Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

Condition or disease Intervention/treatment Phase
Birch Pollen Allergy Biological: Recombinant birch pollen Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309062


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

Additional Information:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00309062     History of Changes
Other Study ID Numbers: Al0103rB
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: March 11, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases