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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
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Grazax Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 812 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Grazax Asthma Prevention
Study Start Date : January 2010
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Evaluation of allergy and asthma symptoms [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Quality of life and adverse events [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Asthma

Information from the National Library of Medicine

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


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

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01061203     History of Changes
Other Study ID Numbers: GT-21
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by ALK-Abelló A/S:
Rhinitis
allergic
Seasonal
grass
Asthma

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases