Grazax Asthma Prevention (GAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01061203
First received: February 1, 2010
Last updated: March 21, 2014
Last verified: March 2014

February 1, 2010
March 21, 2014
January 2010
September 2015   (final data collection date for primary outcome measure)
Evaluation of allergy and asthma symptoms [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01061203 on ClinicalTrials.gov Archive Site
Quality of life and adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Grazax Asthma Prevention
Grazax Asthma Prevention

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Allergic Rhinitis
  • Drug: Grazax
    Treatment with 75.000 SQ-T once daily
  • Drug: Placebo
    Tablet with no active grass component.
  • Active Comparator: Grazax
    Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.
    Intervention: Drug: Grazax
  • Placebo Comparator: Tablet with no active grass
    Tablet with no active grass component. One tablet per day administered under the tongue.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Asthma
Both
5 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01061203
GT-21
No
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Principal Investigator: Erkka Valovirta, MD Terveystalo Turku, Finland
ALK-Abelló A/S
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP