Efficacy and Safety of Grazax in Children
Phase 3
Completed
- Conditions
- Allergy
- 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
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which Grazax modulates immune responses in pediatric grass pollen allergy?
How does Grazax compare to conventional antihistamines in reducing rhinoconjunctivitis symptoms in children?
Which biomarkers correlate with improved outcomes in children receiving sublingual immunotherapy like Grazax?
What are the long-term safety profiles of Grazax in pediatric populations with comorbid asthma?
Are there combination therapies involving Grazax that enhance efficacy in grass pollen-induced allergic rhinitis?
Trial Locations
- Locations (1)
Tangstedter Landstrasse 77
🇩🇪Hamburg, Germany
Tangstedter Landstrasse 77🇩🇪Hamburg, Germany