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Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture

NCT00264459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2014-01-24

No results posted yet for this study

Summary

The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture

Conditions

  • Grass Pollen Allergy

Interventions

BIOLOGICAL

Grass pollen formulation

Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.

OTHER

Comparator

Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.

Sponsors & Collaborators

  • Allergopharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Ludger Klimek, 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
2003-02-28
Primary Completion
2008-08-31
Completion
2011-09-30

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 NCT00264459 on ClinicalTrials.gov