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Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis

NCT01731249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2012-11-27

No results posted yet for this study

Summary

The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.

Conditions

Interventions

BIOLOGICAL

Placebo

10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years

BIOLOGICAL

Birch pollen allergen extract

Sublingual solution of Birch pollen allergen extract 300IR (10 actuations) once daily 5 months per year and during 2 years

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Aptuit

    collaborator INDUSTRY

  • Cenduit LLC

    collaborator INDUSTRY

  • PHT Corporation

    collaborator INDUSTRY

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Margitta WORM, MD, PR · Allergie-Centrum-Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin, Charitéplatz 1, 10117 Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-07-31
Completion
2012-10-31

Countries

  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Latvia
  • Lithuania
  • Poland
  • Slovakia
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01731249 on ClinicalTrials.gov