Intraseasonal Short-time Up-dosing With Alutard SQ Grasses
A Randomised, Parallel-group, Double-blind, Placebo-controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-seasonal Short-time Updosing Schedule for Alutard SQ
1 other identifier
interventional
149
1 country
1
Brief Summary
Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 12, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedDecember 29, 2015
December 1, 2015
6 months
September 30, 2008
December 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Changes from baseline in Immuno globuline E (IgE)-blocking factor
9 weeks
Secondary Outcomes (1)
Tolerability
9 weeks
Study Arms (2)
Allergy vaccination
ACTIVE COMPARATORAllergy 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
Subcutaneous injections
PLACEBO COMPARATORPlacebo injections
Interventions
Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days
Eligibility Criteria
You may qualify if:
- history of grass pollen induced allergic rhinoconjunctivitis
- positive skin prick test
You may not qualify if:
- uncontrolled severe bronchial asthma
- previous treatment with immunotherapy within the previous 5 years
- contraindication for specific immunotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ALK-Abelló A/Slead
Study Sites (1)
Center for Rhinology and Allergology
Wiesbaden, D-65183, Germany
Related Publications (1)
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.
PMID: 23063373RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ludger Klimek, MD
Center for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2008
First Posted
December 12, 2008
Study Start
April 1, 2008
Primary Completion
October 1, 2008
Study Completion
January 1, 2009
Last Updated
December 29, 2015
Record last verified: 2015-12