Grazax Asthma Prevention (GAP)
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|ClinicalTrials.gov Identifier: NCT01061203|
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : September 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Drug: Grazax Drug: Placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||812 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Grazax Asthma Prevention|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Active Comparator: Grazax
Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.
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.
Tablet with no active grass component.
- Evaluation of allergy and asthma symptoms [ Time Frame: 5 years ]
- Quality of life and adverse events [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061203
|Turku, Finland, 20100|
|Principal Investigator:||Erkka Valovirta, MD||Terveystalo Turku, Finland|