Grazax Asthma Prevention (GAP)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ALK-Abelló A/S Identifier:
First received: February 1, 2010
Last updated: June 23, 2015
Last verified: June 2015
Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy

Condition Intervention Phase
Allergic Rhinitis
Drug: Grazax
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Grazax Asthma Prevention

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Evaluation of allergy and asthma symptoms [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life and adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: January 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Grazax
Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.
Drug: Grazax
Treatment with 75.000 SQ-T once daily
Placebo Comparator: Tablet with no active grass
Tablet with no active grass component. One tablet per day administered under the tongue.
Drug: Placebo
Tablet with no active grass component.

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.


Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Asthma
  Contacts and Locations
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Please refer to this study by its identifier: NCT01061203

Terveystalo Turku
Turku, Finland, 20100
Sponsors and Collaborators
ALK-Abelló A/S
Principal Investigator: Erkka Valovirta, MD Terveystalo Turku, Finland
  More Information

Responsible Party: ALK-Abelló A/S Identifier: NCT01061203     History of Changes
Other Study ID Numbers: GT-21 
Study First Received: February 1, 2010
Last Updated: June 23, 2015
Health Authority: Austria: Federal Office for Safety in Health Care
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Norway: Norwegian Medicines Agency
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ALK-Abelló A/S:

Additional relevant MeSH terms:
Rhinitis, Allergic
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Rhinitis processed this record on May 25, 2016