NCT00264459

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

A Multicentre, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of a Perennial Sublingual Specific Immunotherapy With a Liquid Formulation of an Extract of a Six Grass Pollen-mixture in Patients With Clinically Relevant Grass Pollen Sensitivity.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Allergopharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2003-02-01
• Primary completion: 2008-08-01
• Completion: 2011-09-01
• First posted: 2005-12-13
• Last updated: 2014-01-24

Locations

1 site across 1 country: Germany