Dose-Response-Study With a Recombinant Cocktail of Phleum (rPhleum) Allergens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00666341
First received: April 21, 2008
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Type I-Allergy
Drug: placebo
Biological: rPhleum
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Systemic reaction (according to Tryba) [ Time Frame: uptitration phase ] [ Designated as safety issue: Yes ]
    Number of patients with at least one systemic reaction (according to Tryba Grade 1-4) with possible, probable or definite relationship to the study medication determined at the end of the uptitration phase.


Secondary Outcome Measures:
  • Late Phase Reactions [ Time Frame: before and at the end of the double-blind phase ] [ Designated as safety issue: Yes ]
    Changes of the Late Phase Reactions in specific intracutaneous test with natural allergen before and at the end of the double-blind placebo controlled phase before grass pollen season.


Enrollment: 50
Study Start Date: September 2007
Study Completion Date: May 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.
Drug: placebo
Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.
Other Name: Comparator
Experimental: 20 μg rPhleum Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)
Other Name: Specific Immunotherapy
Experimental: 40 μg rPhleum Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
Other Name: Specific Immunotherapy
Experimental: 80 μg rPhleum Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
Other Name: Specific Immunotherapy
Experimental: 120 μg rPhleum Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
Other Name: Specific Immunotherapy

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

Additional Information:
No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00666341     History of Changes
Other Study ID Numbers: AL0701rP, 2007-002808-18
Study First Received: April 21, 2008
Last Updated: November 7, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014