NCT00408616

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

March 9, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

December 6, 2006

Last Update Submit

March 6, 2009

Conditions

Allergy

Outcome Measures

Primary Outcomes (2)

  • Hayfever symptoms

    Grass pollen season 2007

  • Intake of hayfever symptom relieving medication

    Grass pollen season 2007

Secondary Outcomes (6)

  • Combined hayfever symptom and medication scores

    Grass pollen season 2007

  • Asthma symptoms and medication

    Grass pollen season 2007

  • Global Evaluation of treatment efficacy

    Grass pollen season 2007

  • Adverse Events

    9 months

  • Pharmacoeconomic Assessment

    9 months

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Grazax treatment

Biological: Grazax-R

2

PLACEBO COMPARATOR

Grazax Placebo

Biological: Grazax Placebo

Interventions

Grazax-RBIOLOGICAL

Grass tablet, 75.000 SQ per day for one year

1
Grazax PlaceboBIOLOGICAL

Grazax Placebo, 0 SQ tablet per day for one year

2

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangstedter Landstrasse 77

Hamburg, 22415, Germany

Location

Related 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. 2009 Jan;123(1):167-173.e7. doi: 10.1016/j.jaci.2008.10.044.

    PMID: 19130937RESULT

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Friedrich Kaiser, Dr. med.

    Tangstedter Landstrasse 77, 22415 Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 6, 2006

First Posted

December 7, 2006

Study Start

November 1, 2006

Primary Completion

September 1, 2007

Study Completion

November 1, 2007

Last Updated

March 9, 2009

Record last verified: 2009-03

Locations

DE(1)