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Open Label Safety Study of a Birch Pollen Allergen Extract

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00818181
First received: January 6, 2009
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    Between Visit 03 and Visit 05 (June 2008 - January 2009)


Secondary Outcome Measures:
  • Systemic reactions [ Time Frame: Entire treatment period ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Leader in specific allergy research and therapy  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00818181     History of Changes
Other Study ID Numbers: AL0206st, 2007-006053-24
Study First Received: January 6, 2009
Last Updated: March 8, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013