Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation (ALLEGRA6)

Allergopharma

Status and phase: Completed; Phase 3

Conditions: Conjunctivitis; Rhinitis; Allergy

Treatments: Biological: Allerslit forte

Study type: Interventional

Funder types: Industry

Identifiers

NCT00623701

AL0703st

2007-000823-16 (EudraCT Number)

Details and patient eligibility

About

Efficacy and Safety from a high-dosed sublingual grass pollen preparation

Enrollment: 126 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Allergic rhinoconjunctivitis attributable to grass pollen
• Positive SPT
• Positive EAST
• Positive provocation Test

Exclusion criteria

• Serious chronic disease
• other perennial allergies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

sublingual placebo preparation

Treatment:

Biological: Allerslit forte

Biological: Allerslit forte

2

Experimental group

Description:

Sublingual preparation, 40 micro grams Phl p 5 maintenance dose

Treatment:

Biological: Allerslit forte

Biological: Allerslit forte