- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01061203
Grazax Asthma Prevention (GAP)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Turku, Finland, 20100
- Terveystalo Turku
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A history of grass pollen allergy
- Positive Skin prick test to grass
- Positive specific IgE to grass
Exclusion Criteria:
- Asthma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of allergy and asthma symptoms
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life and adverse events
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erkka Valovirta, MD, Terveystalo Turku, Finland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GT-21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergic Rhinitis
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
ALK-Abelló A/SCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
West Penn Allegheny Health SystemPennsylvania Allergy and Asthma Research FoundationCompletedAllergy | Perennial Allergic Rhinitis | Seasonal Allergic RhinitisUnited States
-
Ahn-Gook Pharmaceuticals Co.,LtdSamsung Medical Center; Seoul St. Mary's Hospital; Seoul National University... and other collaboratorsCompletedAllergic Rhinitis | Perennial Allergic Rhinitis | Non-seasonal Allergic RhinitisKorea, Republic of
-
Glenmark Specialty S.A.CompletedSeasonal Allergic Rhinitis (SAR)United States
Clinical Trials on Grazax
-
ALK-Abelló A/SCompletedAllergic RhinoconjunctivitisGermany
-
ALK-Abelló A/SCompletedAllergic RhinoconjunctivitisFrance
-
ALK-Abelló A/SCompletedAllergic RhinoconjunctivitisSpain
-
ALK-Abelló A/SCompletedAllergic Rhinitis Due to Grass PollensSpain
-
Imperial College LondonKing's College London; Wellcome Trust; ALK-Abelló A/SCompletedAllergic RhinitisUnited Kingdom
-
ALK-Abelló A/SCompletedGrass Pollen AllergyDenmark
-
Imperial College LondonCompleted
-
AbbottCompletedSeasonal Allergic RhinitisRussian Federation