This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks). The primary parameter will be the proportion of patients who experience systemic reactions \> grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached. It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
subcutaneous injections of increasing doses according to the described regimen
Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie
Bonn, Germany
Practice Blum
Dortmund, Germany
Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO
Dresden, Germany
systemic reactions > grade I or large local reactions related to injection
Time frame: 24 hrs after injection
specific serum IgE and IgG concentrations
Time frame: 16 weeks
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Practice Thieme
Duisburg, Germany
Medaimun GmbH
Frankfurt, Germany
Practice Wrede
Herford, Germany
Dr. med. Jörg Michael Nebel
Koblenz, Germany
Practice Scholz
Mahlow, Germany
St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie
Mönchengladbach, Germany
Practice Termeer
Stuttgart, Germany
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