Open Label Safety Study of a Birch Pollen Allergen Extract
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|ClinicalTrials.gov Identifier: NCT00818181|
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : March 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Rhinoconjunctivitis||Drug: Biological: AL0206st||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Open Label Safety Study of a Sublingual Specific Immunotherapy With a Solution of Birch Pollen Allergen Extract in Patients With Clinically Relevant Birch Pollen Allergy|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||August 2010|
Experimental: Solution of birch pollen allergen extract
In total up to 4 drops (dose for maintainace therapy)are administered under the tongue.
|Drug: Biological: AL0206st|
- number of patients with at least one adverse event [ Time Frame: 8 months ]Between Visit 03 and Visit 05 (June 2008 - January 2009)
- Systemic reactions [ Time Frame: Entire treatment period ]The occurrence of systemic reactions during the entire treatment period: For this purpose patients completed a diary covering the treatment phase.
- Immunologic parameters [ Time Frame: during the course of the study ]Immunologic parameters (IgE, IgG1 and IgG4) were evaluated during the course of the study in order to obtain evidence of the immunologic effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818181
|Prof. Dr. Nicolas Hunzelmann|
|Cologne, Germany, 50931|
|Principal Investigator:||Nicolas Hunzelmann, Prof. Dr.||University of Cologne|