Grazax Asthma Prevention

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01061203

Acronym

GAP

Enrollment

812

Registered

2010-02-03

Start date

2010-01-31

Completion date

2015-09-30

Last updated

2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Rhinitis, allergic, Seasonal, grass, Asthma

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.

Interventions

DRUGGrazax

Treatment with 75.000 SQ-T once daily

DRUGPlacebo

Tablet with no active grass component.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 12 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Asthma

Design outcomes

Primary

Measure	Time frame
Evaluation of allergy and asthma symptoms	5 years

Secondary

Measure	Time frame
Quality of life and adverse events	5 years

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026