Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00263627
First received: December 8, 2005
Last updated: November 7, 2013
Last verified: November 2013

December 8, 2005
November 7, 2013
June 2005
June 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00263627 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens
A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens

This study is an evaluation of the safety and efficacy of specific immunotherapy with a birch pollen allergoid.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pollen Allergy
Biological: Birch pollen allergoid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2010
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Rhinitis
  • Rhinoconjunctivitis
  • Positive skin prick test to birch pollen
  • Positive radioallergosorbent test (RAST) to birch pollen
  • Positive provocation test result to birch pollen

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00263627
Al0204AV, 2005-000025-35
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Allergopharma GmbH & Co. KG
Allergopharma GmbH & Co. KG
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Principal Investigator: Annemie Narkus, M.D.
Allergopharma GmbH & Co. KG
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP