Tolerability of Grazax in Patients With Hayfever in Real Life Settings

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01433510

Acronym

GRAAL

Enrollment

628

Registered

2011-09-14

Start date

2007-11-30

Completion date

2010-12-31

Last updated

2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergic, Rhinoconjunctivitis, Immunotherapy

Brief summary

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

Detailed description

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

Interventions

DRUGGrazax

1 tablet/day - pre and co-seasonal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events related to Grazax	From November 2007 to October 2010 (3 years)	All adverse events were reported according to the MedDRA dictionary

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026