Intraseasonal Short-time Up-dosing With Alutard SQ Grasses
Phase 3
Completed
- Conditions
- Allergy
- Interventions
- Biological: Allergy vaccination (Alutard SQ)
- Registration Number
- NCT00807547
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
Inclusion Criteria
- history of grass pollen induced allergic rhinoconjunctivitis
- positive skin prick test
Exclusion Criteria
- uncontrolled severe bronchial asthma
- previous treatment with immunotherapy within the previous 5 years
- contraindication for specific immunotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subcutaneous injections Allergy vaccination (Alutard SQ) Placebo injections Allergy vaccination Allergy vaccination (Alutard SQ) 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
- Primary Outcome Measures
Name Time Method Changes from baseline in Immuno globuline E (IgE)-blocking factor 9 weeks
- Secondary Outcome Measures
Name Time Method Tolerability 9 weeks
Trial Locations
- Locations (1)
Center for Rhinology and Allergology
🇩🇪Wiesbaden, Germany