Efficacy and Safety of Grazax in Children

Allergy Clinical Trial

Official title:

A Phase III Trial Investigating the Efficacy and Safety of Grazax in Children Aged 5-16 Years With Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408616
• Other study ID #: GT-12
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2006
• Last updated: March 6, 2009
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: March 2009
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: November 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• Boys and girls 5-16 years of age

• A clinical history of grass pollen induced hayfever

• Positive Skin Prick Test to Phleum pratense

• Positive specific IgE against Phleum pratense

Exclusion Criteria:

• History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season

• History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed

• History of severe asthma

• Current severe atopic dermatitis

Study Design

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

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• Grazax-R
Grass tablet, 75.000 SQ per day for one year
• Grazax Placebo
Grazax Placebo, 0 SQ tablet per day for one year

Locations

Country	Name	City	State
Germany	Tangstedter Landstrasse 77	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, Knecht R, Stephan V, Tholstrup B, Weisshaar C, Kaiser F. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hayfever symptoms		Grass pollen season 2007	No
Primary	Intake of hayfever symptom relieving medication		Grass pollen season 2007	No
Secondary	Combined hayfever symptom and medication scores		Grass pollen season 2007	No
Secondary	Asthma symptoms and medication		Grass pollen season 2007	No
Secondary	Global Evaluation of treatment efficacy		Grass pollen season 2007	No
Secondary	Adverse Events		9 months	Yes
Secondary	Pharmacoeconomic Assessment		9 months	No
Secondary	Immunological Assessment		9 months	No