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

November 7, 2013 updated by: Allergopharma GmbH & Co. KG

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-W.
      • Wiesbaden, Baden-W., Germany, 68167
        • Prof. Dr. med. Ludger Klimek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
Other Names:
  • 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 1 (20 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
Other Names:
  • 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 1 (20 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
Other Names:
  • 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 1 (20 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
Other Names:
  • Specific Immunotherapy
Biological: rPhleum
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
Other Names:
  • Specific Immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic reaction (according to Tryba)
Time Frame: uptitration phase
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.
uptitration phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late Phase Reactions
Time Frame: before and at the end of the double-blind phase
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.
before and at the end of the double-blind phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergopharma GmbH & Co. KG

Investigators

  • Study Chair: Karl Hörmann, MD, Universitätsklinikum Mannheim GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL0701rP
  • 2007-002808-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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