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

NCT00666341 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-11-08

No results posted yet for this study

Summary

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

Conditions

  • Type I-Allergy

Interventions

DRUG

placebo

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

BIOLOGICAL

rPhleum

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 2 (40 μg)

BIOLOGICAL

rPhleum

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 4 (120 μg)

Sponsors & Collaborators

  • Allergopharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Karl Hörmann, MD · Universitätsklinikum Mannheim GMBH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-01-31
Completion
2010-05-31

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00666341 on ClinicalTrials.gov