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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014