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Open Label Safety Study of a Birch Pollen Allergen Extract

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00818181
First Posted: January 7, 2009
Last Update Posted: March 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
  Purpose
This trial is performed to assess safety of a sublingual birch pollen extract.

Condition Intervention Phase
Rhinoconjunctivitis Drug: Biological: AL0206st Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:
  • number of patients with at least one adverse event [ Time Frame: 8 months ]
    Between Visit 03 and Visit 05 (June 2008 - January 2009)


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 73
Study Start Date: June 2008
Study Completion Date: August 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allergic rhinoconjunctivitis attributable to birch pollen
  • Positive SPT
  • Positive EAST

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies
  • Partly controlled asthma
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Germany
Prof. Dr. Nicolas Hunzelmann
Cologne, Germany, 50931
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Nicolas Hunzelmann, Prof. Dr. University of Cologne
  More Information

Additional Information:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00818181     History of Changes
Other Study ID Numbers: AL0206st
2007-006053-24 ( EudraCT Number )
First Submitted: January 6, 2009
First Posted: January 7, 2009
Last Update Posted: March 11, 2013
Last Verified: March 2013

Keywords provided by Allergopharma GmbH & Co. KG:
Type I - Allergy, rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases