Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children
|Allergic Rhinoconjunctivitis||Biological: Grass pollen allergens in a water/glycerol solution Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo|
- Changes of Symptom-Medication-Score [ Time Frame: After 1 year of treatment ]The change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment.
- Evaluation of the documentation of adverse events (AEs) [ Time Frame: Entire treatment period ]Safety of treatments during the entire treatment period.
|Study Start Date:||February 2008|
|Study Completion Date:||August 2015|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Grass pollen allergens in a water/glycerol solution
Biological: Grass pollen allergens in a water/glycerol solution
In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.
Other Name: Allerslit forte grasses
Placebo Comparator: Placebo
Water/glycerol solution with phosphate buffered saline
Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.
Other Name: Comparator
Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.
Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.
In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841256
|Klinik für Paediatrie Universitätsmedizin Berlin|
|Berlin, Germany, 13353|
|Principal Investigator:||Ulrich Wahn, MD||Charite University, Berlin, Germany|