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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2011-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Grass Pollen Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo was given the same way as a sublingual preparation.

Group Type PLACEBO_COMPARATOR

Comparator

Intervention Type OTHER

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

Liquid formulation of an extract of a 6 grass pollen mixture

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.

Group Type EXPERIMENTAL

Grass pollen formulation

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Comparator

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

Intervention Type OTHER

Other Intervention Names

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specific immunotherapy Specific Immunotherapy

Eligibility Criteria

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Inclusion Criteria

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