Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006053-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is performed to assess safety of a sublingual birch pollen extract.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solution of birch pollen allergen extract | Experimental | In total up to 4 drops (dose for maintainace therapy)are administered under the tongue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological: AL0206st | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with at least one adverse event | Between Visit 03 and Visit 05 (June 2008 - January 2009) | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic reactions | The occurrence of systemic reactions during the entire treatment period: For this purpose patients completed a diary covering the treatment phase. | Entire treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Immunologic parameters | Immunologic parameters (IgE, IgG1 and IgG4) were evaluated during the course of the study in order to obtain evidence of the immunologic effects. | during the course of the study |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Hunzelmann, Prof. Dr. | University of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. Nicolas Hunzelmann | Cologne | 50931 | Germany |
Not provided
| Label | URL |
|---|---|
| Leader in specific allergy research and therapy | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided