Grazax Asthma Prevention (GAP)

September 7, 2016 updated by: ALK-Abelló A/S
Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

812

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20100
        • Terveystalo Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: Erkka Valovirta, MD, Terveystalo Turku, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

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.

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