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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005911-82 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy | Experimental | Grass pollen allergens in a water/glycerol solution |
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| Placebo | Placebo Comparator | Water/glycerol solution with phosphate buffered saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grass pollen allergens in a water/glycerol solution | Biological | In total up to 4 drops (dose for maintenance therapy) are administered under the tongue. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes of Symptom-Medication-Score | 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. | After 1 year of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the documentation of adverse events (AEs) | Safety of treatments during the entire treatment period. | Entire treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Wahn, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Paediatrie Universitätsmedizin Berlin | Berlin | State of Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22939758 | Result | Wahn U, Klimek L, Ploszczuk A, Adelt T, Sandner B, Trebas-Pietras E, Eberle P, Bufe A; SLIT Study Group. High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: a double-blind, placebo-controlled study. J Allergy Clin Immunol. 2012 Oct;130(4):886-93.e5. doi: 10.1016/j.jaci.2012.06.047. Epub 2012 Aug 29. |
| Label | URL |
|---|---|
| Leader in specific allergy research and therapy | View source |
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| Placebo | Drug | 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. |
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| Click here for information about this trial in the European Clinical Trials Register | View source |