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Completed

NCT Number: NCT01061203

Grazax Asthma Prevention

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

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Key information

Conditions

Allergic Rhinitis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Terveystalo Turku

Turku, 20100, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Asthma

Treatment and study plan

GRAZAX

Drug

Treatment with 75.000 SQ-T once daily

Placebo

Drug

Tablet with no active grass component.

Primary outcomes

  1. Evaluation of allergy and asthma symptoms

    Time frame: 5 years

Secondary outcomes

  1. Quality of life and adverse events

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Acronym: GAP

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2010
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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