... 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
Overview
- Phase
- Phase 3
- Intervention
- Grass pollen allergens in a water/glycerol solution
- Conditions
- Allergic Rhinoconjunctivitis
- Sponsor
- Allergopharma GmbH & Co. KG
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- Changes of Symptom-Medication-Score
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •4 - \<12 years (at the time of inclusion)
- •Positive SPT
- •Positive EAST
- •Positive CPT
Exclusion Criteria
- •Serious chronic diseases
- •Other perennial allergies
Arms & Interventions
Immunotherapy
Grass pollen allergens in a water/glycerol solution
Intervention: Grass pollen allergens in a water/glycerol solution
Placebo
Water/glycerol solution with phosphate buffered saline
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Evaluation of the documentation of adverse events (AEs)(Entire treatment period)