Grazax Asthma Prevention | NCT01061203

Studies
Grazax Asthma Prevention

NCT01061203

Sponsor

ALK-Abelló A/S

Status

Completed

Last Update Posted

Sep 8, 2016Estimated

Enrollment

812Actual

Phase

Phase 3

Conditions

Allergic Rhinitis

Interventions

Grazax
Placebo

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Feb 1, 2010

First Submission Date that Met QC Criteria

Feb 1, 2010

First Posted Date

Feb 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2016

Last Update Posted Date

Sep 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

812Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Grazax	Active Comparator	Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.	Drug: Grazax
Tablet with no active grass	Placebo Comparator	Tablet with no active grass component. One tablet per day administered under the tongue.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Grazax	Drug	Treatment with 75.000 SQ-T once daily	Grazax
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of allergy and asthma symptoms		5 years

Secondary Outcomes

Measure	Description	Time Frame
Quality of life and adverse events		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Asthma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erkka Valovirta, MD	Terveystalo Turku, Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Terveystalo Turku		Turku		20100	Finland

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D001249	Asthma

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C551013	Grazax

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided