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SUBLIVAC® Birch PROBE Study

NCT00932607 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-02-07

No results posted yet for this study

Summary

Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC Birch is also effective compared to treatment with Staloral Birch by means of reduction in allergic symptoms during nasal provocation in subjects suffering from IgE mediated allergic complaints triggered by birch pollen.

Conditions

  • Seasonal Rhinitis and/or Rhinoconjunctivitis
  • Birch Pollen Allergy

Interventions

DRUG

sublingual immunotherapy

Start with 1 drop daily of SUBLIVAC Birch and increase by 1 drop daily, until the maintenance dose of 5 drops is reached. This maintenance dose should then be taken daily. Or 1 puff of Staloral Birch 10 I.R./ml on day one, 2 puffs on day two and increase by 2 puffs until at day six 10 puffs are reached. At day seven 1 puff of Staloral Birch 300 I.R./ml is taken, at day eight 2 puffs and day nine 4 puffs. From then on 4 puffs daily are taken. Route of administration: Sublingual application. Drops (for SUBLIVAC Birch) or puffs (for Staloral Birch) are to be held underneath the tongue and then will be swallowed. Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy).

Sponsors & Collaborators

  • HAL Allergy

    lead INDUSTRY

Principal Investigators

  • Ludger Klimek, PhD · Zentrum für Rhinologie & Allergologie D-Wiesbaden

  • Oliver Pfaar, MD · Zentrum für Rhinologie & Allergologie D-Wiesbaden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-02-28

Countries

  • Germany

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 NCT00932607 on ClinicalTrials.gov