NCT01061203

Grazax Asthma Prevention

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 812 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Grazax	Treatment with 75.000 SQ-T once daily
DRUG	Placebo	Tablet with no active grass component.

Timeline

• Start date: 2010-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2010-02-03
• Last updated: 2016-09-08

Locations

1 site across 1 country: Finland