Grazax Asthma Prevention

ALK-Abelló A/S812 enrolled

Overview

Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy

Investigation of the effect of Grazax (ALK produced grass tablet) on asthma prevention in children with grass pollen allergy. Children in the age of 6-12 years will be randomised to either placebo or Grazax treatment. Grazax has been approved for treatment of grass pollen allergy in adults and children, diagnosed with a positive skin prick test and/or specific immunoglobulin (IgE) test to grass pollen and with clinically relevant symptoms. This study will explore prevention of asthma in children with grass pollen induced allergy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

812

Conditions

Allergic Rhinitis

Interventions

GrazaxDRUG

Treatment with 75.000 SQ-T once daily

PlaceboDRUG

Tablet with no active grass component.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A history of grass pollen allergy * Positive Skin prick test to grass * Positive specific IgE to grass Exclusion Criteria: * Asthma

Locations (1)

Terveystalo Turku

Turku, Finland

Outcomes

Primary Outcomes

Evaluation of allergy and asthma symptoms

Time frame: 5 years

Secondary Outcomes

Quality of life and adverse events

Time frame: 5 years

Data from ClinicalTrials.gov

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