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Grazax Asthma Prevention (GAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061203
First Posted: February 3, 2010
Last Update Posted: September 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ALK-Abelló A/S
  Purpose
Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy

Condition Intervention Phase
Allergic Rhinitis Drug: Grazax Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Grazax Asthma Prevention

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

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

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

Enrollment: 812
Study Start Date: January 2010
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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
  Contacts and Locations
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
  More Information

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01061203     History of Changes
Other Study ID Numbers: GT-21
First Submitted: February 1, 2010
First Posted: February 3, 2010
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