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

Allergopharma

Status and phase: Completed; Phase 3

Conditions: Grass Pollen Allergy

Treatments: Biological: Grass pollen formulation; Other: Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264459

Al0102st

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo was given the same way as a sublingual preparation.

Treatment:

Other: Comparator

Liquid formulation of an extract of a 6 grass pollen mixture

Experimental group

Description:

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.

Treatment:

Biological: Grass pollen formulation