Grazax Asthma Prevention

Allergic Rhinitis Clinical Trial

— GAP  

Official title:

Grazax Asthma Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061203
• Other study ID #: GT-21
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2010
• Last updated: September 7, 2016
• Start date: January 2010
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutNorway: Norwegian Medicines AgencySpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• A history of grass pollen allergy

• Positive Skin prick test to grass

• Positive specific IgE to grass

Exclusion Criteria:

• Asthma

Study Design

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
Finland	Terveystalo Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of allergy and asthma symptoms		5 years	Yes
Secondary	Quality of life and adverse events		5 years	Yes