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Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens

NCT00263627 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2014-07-03

No results posted yet for this study

Summary

The aim of this clinical trial is to show safety and efficacy of the allergoid preparation of birch pollen allergens in the treatment of birch allergic patients in a representative number of patients.

Conditions

  • Pollen Allergy

Interventions

BIOLOGICAL

Birch pollen allergoid

Subcutaneous injections were applied in the upper arm. Vials with three different concentrations were used: Strength A (1000 TU/mL), strength B (10 000 TU/mL) and strength 0 (100 TU/mL) by dilution of strength A.

OTHER

Placebo

Sterile aluminium hydroxide suspension for subcutaneous injection were applied in the upper arm. Vials with strength A contained 0.0125 mg/mL and with strength B 0.125 mg/mL histamine-dihydrochloride and strength 0 was produced by dilution of strength A. The vials containing the placebo solution were identical in their outer appearance with the active study preparation of the birch pollen allergoids.

Sponsors & Collaborators

  • Allergopharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Annemie Narkus, M.D.

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
2005-06-30
Primary Completion
2007-06-30
Completion
2010-03-31

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 NCT00263627 on ClinicalTrials.gov