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|
|Primary Completion Date :||September 2015|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061203
|Turku, Finland, 20100|
|Principal Investigator:||Erkka Valovirta, MD||Terveystalo Turku, Finland|