Open Label Safety Study of a Birch Pollen Allergen Extract

March 8, 2013 updated by: Allergopharma GmbH & Co. KG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50931
        • Prof. Dr. Nicolas Hunzelmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies
  • Partly controlled asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with at least one adverse event
Time Frame: 8 months
Between Visit 03 and Visit 05 (June 2008 - January 2009)
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Entire treatment period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the course of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergopharma GmbH & Co. KG

Investigators

  • Principal Investigator: Nicolas Hunzelmann, Prof. Dr., University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

March 11, 2013

Last Update Submitted That Met QC Criteria

March 8, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL0206st
  • 2007-006053-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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