Efficacy and Safety of Grazax in Children
Phase 3
Completed
- Conditions
- Allergy
- Interventions
- Biological: Grazax PlaceboBiological: Grazax-R
- Registration Number
- NCT00408616
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 253
Inclusion Criteria
- Boys and girls 5-16 years of age
- A clinical history of grass pollen induced hayfever
- Positive Skin Prick Test to Phleum pratense
- Positive specific IgE against Phleum pratense
Exclusion Criteria
- History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
- History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
- History of severe asthma
- Current severe atopic dermatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Grazax Placebo Grazax Placebo 1 Grazax-R Grazax treatment
- Primary Outcome Measures
Name Time Method Hayfever symptoms Grass pollen season 2007 Intake of hayfever symptom relieving medication Grass pollen season 2007
- Secondary Outcome Measures
Name Time Method Combined hayfever symptom and medication scores Grass pollen season 2007 Asthma symptoms and medication Grass pollen season 2007 Global Evaluation of treatment efficacy Grass pollen season 2007 Adverse Events 9 months Pharmacoeconomic Assessment 9 months Immunological Assessment 9 months
Trial Locations
- Locations (1)
Tangstedter Landstrasse 77
🇩🇪Hamburg, Germany