Open Label Safety Study of a Birch Pollen Allergen Extract

Phase 2

Completed

• Conditions: Rhinoconjunctivitis

• Registration Number: NCT00818181
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2009-02
• Study Completion: 2010-08
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-08
• Last Update Posted: 2013-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
number of patients with at least one adverse event	8 months	Between Visit 03 and Visit 05 (June 2008 - January 2009)

Secondary Outcome Measures

Name	Time	Method
Systemic reactions	Entire treatment period	The occurrence of systemic reactions during the entire treatment period: For this purpose patients completed a diary covering the treatment phase.

Trial Locations

Locations (1)

Prof. Dr. Nicolas Hunzelmann; 🇩🇪 Cologne, Germany