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

April 21, 2008
November 7, 2013
September 2007
January 2009   (final data collection date for primary outcome measure)
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.
The primary endpoint of this study is the 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 up-titration phase [ Time Frame: November 2007 - July 2008 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00666341 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Dose-Response-Study With a Recombinant Cocktail of Phleum (rPhleum) Allergens
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type I-Allergy
  • Drug: placebo
    Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.
    Other Name: Comparator
  • Biological: rPhleum
    Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)
    Other Name: Specific Immunotherapy
  • Biological: rPhleum
    Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
    Other Name: Specific Immunotherapy
  • Biological: rPhleum
    Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
    Other Name: Specific Immunotherapy
  • Biological: rPhleum
    Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
    Other Name: Specific Immunotherapy
  • Placebo Comparator: Placebo
    Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.
    Intervention: Drug: placebo
  • Experimental: 20 μg rPhleum Immunotherapy
    Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)
    Intervention: Biological: rPhleum
  • Experimental: 40 μg rPhleum Immunotherapy
    Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
    Intervention: Biological: rPhleum
  • Experimental: 80 μg rPhleum Immunotherapy
    Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
    Intervention: Biological: rPhleum
  • Experimental: 120 μg rPhleum Immunotherapy
    Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
    Intervention: Biological: rPhleum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2010
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00666341
AL0701rP, 2007-002808-18
Yes
Allergopharma GmbH & Co. KG
Allergopharma GmbH & Co. KG
Not Provided
Study Chair: Karl Hörmann, MD Universitätsklinikum Mannheim GMBH
Allergopharma GmbH & Co. KG
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP