Efficacy and Safety Trial of SLITone Birch in Subjects With Hayfever

This study has been completed.

First Received: April 2, 2006 Last Updated: March 4, 2008 History of Changes

Sponsored by:	ALK-Abelló A/S
Information provided by:	ALK-Abelló A/S
ClinicalTrials.gov Identifier:	NCT00310466

Purpose

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Condition	Intervention	Phase
Allergy	Biological: Sublingual immunotherapy	Phase III

MedlinePlus related topics: Allergy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicentre, Randomised, Double-Blind,Placebo-Controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLIT One Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	200
Study Start Date:	June 2005
Estimated Study Completion Date:	November 2006

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310466

Locations

Germany
Charité Klinik für Dermatologie, Venerologie und Allergologie
Berlin, Germany, D-10117

Sponsors and Collaborators

ALK-Abelló A/S

Investigators

Study Director:	Hendrik Wolf, PhD	ALK-SCHERAX Arzneimittel GmbH
Principal Investigator:	Margitta Worm, MD, Prof.	Charité, Berlin

More Information

No publications provided

Study ID Numbers:	SHX0712
Study First Received:	April 2, 2006
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00310466 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Hypersensitivity
Rhinitis, Allergic, Seasonal

ClinicalTrials.gov processed this record on May 07, 2009