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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00309036
First received: March 30, 2006
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

The trial is performed to assess efficacy and safety of a recombinant grass Pollen allergen cocktail in allergic rhinoconjunctivitis


Condition Intervention Phase
Allergy
 Biological: Recombinant grass 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 Cocktail of Recombinant Derivatives of Major Allergens of Timothy Grass (Phleum Pratense).

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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

Study Start Date: January 2004
Study Completion Date: May 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious chronic diseases
  • Other relevant perennial allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309036

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

Additional Information:
Leader in specific allergy research and therapy  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00309036     History of Changes
Other Study ID Numbers: Al0403rP
Study First Received: March 30, 2006
Last Updated: March 8, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013