Grazax Asthma Prevention

Phase 3

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: Grazax

• Registration Number: NCT01061203
• Lead Sponsor: ALK-Abelló A/S

Brief 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 812

Inclusion Criteria

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

Exclusion Criteria

• Asthma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tablet with no active grass	Placebo	Tablet with no active grass component. One tablet per day administered under the tongue.
Grazax	Grazax	Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.

Primary Outcome Measures

Name	Time	Method
Evaluation of allergy and asthma symptoms	5 years

Secondary Outcome Measures

Name	Time	Method
Quality of life and adverse events	5 years

Trial Locations

Locations (1)

Terveystalo Turku; 🇫🇮 Turku, Finland