Back to resultsOpen Label Safety Study of a Birch Pollen Allergen Extract
Primary Purpose
Rhinoconjunctivitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Biological: AL0206st
Sponsored by
About this trial
This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring Type I - Allergy, rhinoconjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Allergic rhinoconjunctivitis attributable to birch pollen
- Positive SPT
- Positive EAST
Exclusion Criteria:
- Serious chronic diseases
- Other perennial allergies
- Partly controlled asthma
Sites / Locations
- Prof. Dr. Nicolas Hunzelmann
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Solution of birch pollen allergen extract
Arm Description
In total up to 4 drops (dose for maintainace therapy)are administered under the tongue.
Outcomes
Primary Outcome Measures
number of patients with at least one adverse event
Between Visit 03 and Visit 05 (June 2008 - January 2009)
Secondary Outcome Measures
Systemic reactions
The occurrence of systemic reactions during the entire treatment period: For this purpose patients completed a diary covering the treatment phase.
Full Information
NCT ID
NCT00818181
First Posted
January 6, 2009
Last Updated
March 8, 2013
Sponsor
Allergopharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00818181
Brief Title
Open Label Safety Study of a Birch Pollen Allergen Extract
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG
4. Oversight
5. Study Description
Brief Summary
This trial is performed to assess safety of a sublingual birch pollen extract.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis
Keywords
Type I - Allergy, rhinoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Solution of birch pollen allergen extract
Arm Type
Experimental
Arm Description
In total up to 4 drops (dose for maintainace therapy)are administered under the tongue.
Intervention Type
Drug
Intervention Name(s)
Biological: AL0206st
Primary Outcome Measure Information:
Title
number of patients with at least one adverse event
Description
Between Visit 03 and Visit 05 (June 2008 - January 2009)
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Systemic reactions
Description
The occurrence of systemic reactions during the entire treatment period: For this purpose patients completed a diary covering the treatment phase.
Time Frame
Entire treatment period
Other Pre-specified Outcome Measures:
Title
Immunologic parameters
Description
Immunologic parameters (IgE, IgG1 and IgG4) were evaluated during the course of the study in order to obtain evidence of the immunologic effects.
Time Frame
during the course of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Allergic rhinoconjunctivitis attributable to birch pollen
Positive SPT
Positive EAST
Exclusion Criteria:
Serious chronic diseases
Other perennial allergies
Partly controlled asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Hunzelmann, Prof. Dr.
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Dr. Nicolas Hunzelmann
City
Cologne
ZIP/Postal Code
50931
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.allergopharma.de
Description
Leader in specific allergy research and therapy
Learn more about this trial
Open Label Safety Study of a Birch Pollen Allergen Extract
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