Safety and Efficacy of Recombinant Grass Pollen Allergen Cocktail 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. Identifier: NCT00309036
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : March 11, 2013
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG

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

Condition or disease Intervention/treatment Phase
Allergy Biological: Recombinant grass 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 Cocktail of Recombinant Derivatives of Major Allergens of Timothy Grass (Phleum Pratense).
Study Start Date : January 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen

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

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

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 identifier (NCT number): NCT00309036

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

Additional Information:
Responsible Party: Allergopharma GmbH & Co. KG Identifier: NCT00309036     History of Changes
Other Study ID Numbers: Al0403rP
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:
Grass pollen