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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 28, 2014