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OpenTrials
Completed

NCT Number: NCT00818181

Open Label Safety Study of a Birch Pollen Allergen Extract

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

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Key information

Conditions

Rhinoconjunctivitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prof. Dr. Nicolas Hunzelmann

Cologne, 50931, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Biological: AL0206st

Drug

Primary outcomes

  1. number of patients with at least one adverse event

    Time frame: 8 months

    Between Visit 03 and Visit 05 (June 2008 - January 2009)

Secondary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Allergopharma GmbH & Co. KG

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 7, 2009
Registry last updated
Mar 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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