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Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever

NCT00310466 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2013-05-14

Study results available
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Summary

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

Conditions

  • Allergy

Interventions

BIOLOGICAL

Sublingual immunotherapy

once daily intake of sublingual drops

BIOLOGICAL

Placebo

once daily intake of sublingual drops

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • Hendrik Wolf, PhD · ALK-SCHERAX Arzneimittel GmbH

  • Margitta Worm, MD, Prof. · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-08-31
Completion
2007-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00310466 on ClinicalTrials.gov