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

NCT ID: NCT00666341

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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Conditions

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Type I-Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.

20 μg rPhleum Immunotherapy

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)

Group Type EXPERIMENTAL

rPhleum

Intervention Type BIOLOGICAL

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)

40 μg rPhleum Immunotherapy

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)

Group Type EXPERIMENTAL

rPhleum

Intervention Type BIOLOGICAL

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)

80 μg rPhleum Immunotherapy

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)

Group Type EXPERIMENTAL

rPhleum

Intervention Type BIOLOGICAL

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)

120 μg rPhleum Immunotherapy

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)

Group Type EXPERIMENTAL

rPhleum

Intervention Type BIOLOGICAL

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)

Interventions

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placebo

Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.

Intervention Type DRUG

rPhleum

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)

Intervention Type BIOLOGICAL

rPhleum

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)

Intervention Type BIOLOGICAL

rPhleum

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)

Intervention Type BIOLOGICAL

rPhleum

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)

Intervention Type BIOLOGICAL

Other Intervention Names

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Comparator Specific Immunotherapy Specific Immunotherapy Specific Immunotherapy Specific Immunotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergopharma GmbH & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl Hörmann, MD

Role: STUDY_CHAIR

Universitätsklinikum Mannheim GMBH

Locations

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Prof. Dr. med. Ludger Klimek

Wiesbaden, Baden-W., Germany

Site Status

Countries

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Germany

Related Links

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http://www.allergopharma.de

Leader in specific allergy research and therapy

https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-002808-18/DE

Click here for information about this trial in the European Clinical Trials Register

Other Identifiers

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2007-002808-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AL0701rP

Identifier Type: -

Identifier Source: org_study_id