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Grazax Asthma Prevention (GAP)

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Finland

Study Type

Interventional

Intervention

Grazax

Placebo

About this trial

This is an interventional prevention trial for Allergic Rhinitis focused on measuring Rhinitis, allergic, Seasonal, grass, Asthma

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Asthma

Sites / Locations

Terveystalo Turku

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Grazax

Tablet with no active grass

Arm Description

Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.

Tablet with no active grass component. One tablet per day administered under the tongue.

Outcomes

Primary Outcome Measures

Evaluation of allergy and asthma symptoms

Secondary Outcome Measures

Quality of life and adverse events

Full Information

NCT ID

NCT01061203

First Posted

February 1, 2010

Last Updated

September 7, 2016

Sponsor

ALK-Abelló A/S

1. Study Identification

Unique Protocol Identification Number

NCT01061203

Brief Title

Grazax Asthma Prevention

Acronym

GAP

Official Title

Grazax Asthma Prevention

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ALK-Abelló A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Rhinitis, allergic, Seasonal, grass, Asthma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

812 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Grazax

Arm Type

Active Comparator

Arm Description

Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.

Arm Title

Tablet with no active grass

Arm Type

Placebo Comparator

Arm Description

Tablet with no active grass component. One tablet per day administered under the tongue.

Intervention Type

Drug

Intervention Name(s)

Grazax

Intervention Description

Treatment with 75.000 SQ-T once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Tablet with no active grass component.

Primary Outcome Measure Information:

Title

Evaluation of allergy and asthma symptoms

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Quality of life and adverse events

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A history of grass pollen allergy Positive Skin prick test to grass Positive specific IgE to grass Exclusion Criteria: Asthma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erkka Valovirta, MD

Organizational Affiliation

Terveystalo Turku, Finland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Terveystalo Turku

City

Turku

ZIP/Postal Code

20100

Country

Finland

12. IPD Sharing Statement

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Grazax Asthma Prevention

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