Grazax Asthma Prevention (GAP)

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Allergic Rhinitis

Treatments: Drug: Grazax; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01061203

GT-21

Details and patient eligibility

About

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

Full description

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.

Enrollment: 812 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A history of grass pollen allergy
• Positive Skin prick test to grass
• Positive specific IgE to grass

Exclusion criteria

• Asthma

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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812 participants in 2 patient groups, including a placebo group

Grazax

Active Comparator group

Description:

Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.

Treatment:

Drug: Grazax

Tablet with no active grass

Placebo Comparator group

Description:

Tablet with no active grass component. One tablet per day administered under the tongue.

Treatment:

Drug: Placebo