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Dose-Response-Study With a Recombinant Cocktail of Phleum (rPhleum) Allergens
This study is ongoing, but not recruiting participants.
Sponsored by: Allergopharma Joachim Ganzer KG
Information provided by: Allergopharma Joachim Ganzer KG
ClinicalTrials.gov Identifier: NCT00666341
  Purpose

Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)


Condition Intervention Phase
Type I-Allergy
Other: placebo
Biological: AL0701rP
Phase II

Drug Information available for: Aluminum hydroxide Algeldrate Aluminum
U.S. FDA Resources
Study Type: Interventional
Official Title: A Double-Blind Placebo-Controlled Dose-Response Study for Evaluation of Safety and Efficacy of Immunotherapy With a Cocktail of Recombinant Major Allergens of Timothy Grass Pollen (Phleum Pratense) Adsorbed to Aluminium Hydroxide in Patients With IgE-Mediated Allergic Rhinitis/Rhinoconjunctivitis With or Without Bronchial Asthma

Further study details as provided by Allergopharma Joachim Ganzer KG:

Primary Outcome Measures:
  • Safety measured in terms of adverse events (AEs)

Arms Assigned Interventions
1: Placebo Comparator Other: placebo
2: Experimental Biological: AL0701rP
3: Experimental Biological: AL0701rP
4: Experimental Biological: AL0701rP
5: Experimental Biological: AL0701rP

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • main symptoms of allergic rhinitis/rhinoconjunctivitis with or without controlled asthma against grass pollen allergens
  • positive SPT
  • positive EAST
  • positive specific provocation test

Exclusion Criteria:

  • serious chronic diseases
  • other perennial allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666341

Locations
Germany, Baden-W.
Prof. Dr. med. Ludger Klimek
Wiesbaden, Baden-W., Germany, 68167
Sponsors and Collaborators
Allergopharma Joachim Ganzer KG
Investigators
Study Chair: Karl Hörmann, MD Universitätsklinikum Mannheim GMBH
  More Information

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

Study ID Numbers: AL0701rP
Study First Received: April 21, 2008
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00666341  
Health Authority: Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:
Hypersensitivity
Asthma
Rhinitis
Aluminum Hydroxide

ClinicalTrials.gov processed this record on January 16, 2009