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Dose Finding Study for Depigoid Birch: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma

NCT01144429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2011-06-08

No results posted yet for this study

Summary

Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the correct dose.

4 concentrations of a birch pollen allergen extract are applied in this study. Duration of therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e. comparison between treatment arms of increased amount of quantities of allergen to provoke a positive CPT at the end of treatment.

Conditions

  • Allergic Rhinitis and/or Rhinoconjunctivitis +- Asthma
  • Immunotherapy, Allergen

Interventions

BIOLOGICAL

Allergoid, allergenic extract of 100% Birch

Subcutaneous injections Build-up = 1 day: 0,1mL + 0,2mL + 0,2mL s.c. in intervals on 30 minutes; Maintenance = 5 x single injection of 0,5 mL s.c. every 4 weeks

Sponsors & Collaborators

  • Laboratorios LETI SL (Study Medication)

    collaborator UNKNOWN

  • Pierrel Research Europe GmbH

    collaborator INDUSTRY

  • Labor Dr. Spranger (Central lab)

    collaborator UNKNOWN

  • Leti Pharma GmbH

    lead INDUSTRY

Principal Investigators

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

  • Angelika Sager, Dr. · Leti Pharma GmbH, Witten, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-02-28
Completion
2011-05-31

Countries

  • Germany
  • Lithuania
  • Poland

Study Locations

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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 NCT01144429 on ClinicalTrials.gov