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NCT00818181 Clinical Trial

Open Label Safety Study of a Birch Pollen Allergen Extract

Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00818181
Other study ID # AL0206st
Secondary ID 2007-006053-24
Status Completed
Phase Phase 2
First received January 6, 2009
Last updated March 8, 2013
Start date June 2008
Est. completion date August 2010

Study information
Verified date March 2013
Source Allergopharma GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

This trial is performed to assess safety of a sublingual birch pollen extract.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date August 2010
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Allergic rhinoconjunctivitis attributable to birch pollen

- Positive SPT

- Positive EAST

Exclusion Criteria:

- Serious chronic diseases

- Other perennial allergies

- Partly controlled asthma

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Biological: AL0206st

Locations
Country Name City State
Germany Prof. Dr. Nicolas Hunzelmann Cologne

Sponsors (1)
Lead Sponsor Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Other 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 No
Primary number of patients with at least one adverse event Between Visit 03 and Visit 05 (June 2008 - January 2009) 8 months Yes
Secondary 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 Yes
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