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SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

NCT01639768 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2013-05-29

No results posted yet for this study

Summary

The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch compared to placebo.

Conditions

  • Allergic Rhinitis
  • Allergic Rhinoconjunctivitis

Interventions

DRUG

SUBLIVAC FIX Birch

Comparison of different dosages to placebo

Sponsors & Collaborators

  • HAL Allergy

    lead INDUSTRY

Principal Investigators

  • Oliver Pfaar, PD. Dr. med. · Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • Czechia
  • Germany
  • 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 NCT01639768 on ClinicalTrials.gov