Tolerability of Grazax in Patients With Hayfever in Real Life Settings

The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.

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Key information

Conditions

Allergic Rhinoconjunctivitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire

Nantes, 44000, France

About this study

To assess the safety profile with Grazax according to the presence or not of polysensitization and/or asthma at enrollment

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

History of grass pollen allergy
Positive skin prick-test and/or positive specific IgE to grass

Exclusion criteria

Severe, unstable or uncontrolled asthma (FEV1<70% of predicted value)

Treatment and study plan

GRAZAX

Drug

1 tablet/day - pre and co-seasonal

Primary outcomes

Adverse Events related to Grazax

Time frame: From November 2007 to October 2010 (3 years)

All adverse events were reported according to the MedDRA dictionary

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

Observational National Clinical Trial of Safety and Tolerance in Patients Suffering of an Allergic Grass Pollen Rhinitis and Treated by Grazax in Real Life Settings

Acronym: GRAAL

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Sep 14, 2011
Registry last updated: May 29, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed