Trial record 1 of 1 for: Grazax Asthma Prevention (GAP) trial

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Grazax Asthma Prevention (GAP)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

ALK-Abelló A/S

ClinicalTrials.gov Identifier:

NCT01061203

First received: February 1, 2010

Last updated: August 27, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2010

Last Updated Date

August 27, 2012

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

September 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of allergy and asthma symptoms [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01061203 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of life and adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Grazax Asthma Prevention

Official Title ^ICMJE

Grazax Asthma Prevention

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Allergic Rhinitis

Intervention ^ICMJE

Drug: Grazax
Treatment with 75.000 SQ-T once daily
Drug: Placebo
Tablet with no active grass component.

Study Arm (s)

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

Intervention: Drug: Grazax
Placebo Comparator: Tablet with no active grass
Tablet with no active grass component. One tablet per day administered under the tongue.

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

September 2015

Estimated Primary Completion Date

September 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Asthma

Gender

Both

Ages

5 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01061203

Other Study ID Numbers ^ICMJE

GT-21

Has Data Monitoring Committee

Responsible Party

ALK-Abelló A/S

Study Sponsor ^ICMJE

ALK-Abelló A/S

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Erkka Valovirta, MD

Terveystalo Turku, Finland

Information Provided By

ALK-Abelló A/S

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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