Grazax Asthma Prevention

Grazax Asthma Prevention

Sponsors

Lead Sponsor: ALK-Abelló A/S

Source ALK-Abelló A/S
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.

Overall Status Completed
Start Date January 2010
Completion Date September 2015
Primary Completion Date September 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Evaluation of allergy and asthma symptoms 5 years
Secondary Outcome
Measure Time Frame
Quality of life and adverse events 5 years
Enrollment 812
Condition
Intervention

Intervention Type: Drug

Intervention Name: Grazax

Description: Treatment with 75.000 SQ-T once daily

Arm Group Label: Grazax

Intervention Type: Drug

Intervention Name: Placebo

Description: Tablet with no active grass component.

Arm Group Label: Tablet with no active grass

Eligibility

Criteria:

Inclusion Criteria:

- A history of grass pollen allergy

- Positive Skin prick test to grass

- Positive specific IgE to grass

Exclusion Criteria:

- Asthma

Gender: All

Minimum Age: 5 Years

Maximum Age: 12 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Erkka Valovirta, MD Principal Investigator Terveystalo Turku, Finland
Location
Facility: Terveystalo Turku
Location Countries

Finland

Verification Date

September 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Grazax

Type: Active Comparator

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

Label: Tablet with no active grass

Type: Placebo Comparator

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

Acronym GAP
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov