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

Phase 3

Completed

• Conditions: Grass Pollen Allergy
• Interventions: Other: Comparator; Biological: Grass pollen formulation

• Registration Number: NCT00264459
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-13
• Primary Completion: 2008-08
• Study Completion: 2011-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,

Exclusion Criteria

Serious chronic diseases, Other perennial allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Comparator	Placebo was given the same way as a sublingual preparation.
Liquid formulation of an extract of a 6 grass pollen mixture	Grass pollen formulation	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. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose.

Primary Outcome Measures

Name	Time	Method
Symptom and Medication Score (SMS)	1.5 years of therapy	The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.

Secondary Outcome Measures

Name	Time	Method
Visual Rating Scale	1.5 years	Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)

Trial Locations

Locations (1)

Allergopharma GmbH & Co. KG; 🇩🇪 Reinbek, Germany