NCT01061203

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
812

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2010

Longer than P75 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

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

5.7 years

First QC Date

February 1, 2010

Last Update Submit

September 7, 2016

Conditions

Allergic Rhinitis

Keywords

RhinitisallergicSeasonalgrassAsthma

Outcome Measures

Primary Outcomes (1)

  • Evaluation of allergy and asthma symptoms

    5 years

Secondary Outcomes (1)

  • Quality of life and adverse events

    5 years

Study Arms (2)

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

GrazaxDRUG

Treatment with 75.000 SQ-T once daily

Grazax
PlaceboDRUG

Tablet with no active grass component.

Tablet with no active grass

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Terveystalo Turku

Turku, 20100, Finland

Location

MeSH Terms

Conditions

Rhinitis, AllergicRhinitisAsthma

Interventions

Grazax

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfectionsBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Erkka Valovirta, MD

    Terveystalo Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 3, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

FI(1)