Intraseasonal Short-time Up-dosing With Alutard SQ Grasses
NCT ID: NCT00807547
Last Updated: 2015-12-29
Study Results
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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COMPLETED
PHASE3
149 participants
INTERVENTIONAL
2008-04-30
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Allergy vaccination
Allergy vaccination by 6 subcutaneous injections to 10,000 SQ-U with 1-3 days intervals, continuation by 2 injections with 10,000 SQ-U with 2-4 weeks intervals
Allergy vaccination (Alutard SQ)
Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days
Subcutaneous injections
Placebo injections
Allergy vaccination (Alutard SQ)
Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days
Interventions
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Allergy vaccination (Alutard SQ)
Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days
Eligibility Criteria
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Inclusion Criteria
* positive skin prick test
Exclusion Criteria
* previous treatment with immunotherapy within the previous 5 years
* contraindication for specific immunotherapy
18 Years
65 Years
ALL
No
Sponsors
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ALK-Abelló A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Ludger Klimek, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, Germany
Locations
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Center for Rhinology and Allergology
Wiesbaden, , Germany
Countries
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References
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Pfaar O, Wolf H, Klimek L, Schnitker J, Wustenberg E. Immunologic effect and tolerability of intra-seasonal subcutaneous immunotherapy with an 8-day up-dosing schedule to 10,000 standardized quality-units: a double-blind, randomized, placebo-controlled trial. Clin Ther. 2012 Oct;34(10):2072-81. doi: 10.1016/j.clinthera.2012.09.006.
Other Identifiers
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SHX0562
Identifier Type: -
Identifier Source: org_study_id