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Tolerability of Grazax in Patients With Hayfever in Real Life Settings (GRAAL)

This study has been completed.
Information provided by (Responsible Party):
ALK-Abelló A/S Identifier:
First received: September 12, 2011
Last updated: September 13, 2011
Last verified: September 2011
The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.

Condition Intervention Phase
Allergic Rhinoconjunctivitis Drug: Grazax Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • 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

Enrollment: 628
Study Start Date: November 2007
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Grazax Tablets 75000 SQT
Timothy Extract
Drug: Grazax
1 tablet/day - pre and co-seasonal

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01433510

Centre Hospitalier Universitaire
Nantes, France, 44000
Sponsors and Collaborators
ALK-Abelló A/S
Principal Investigator: François FW Wessel, MD Centre Hospitalier Universitaire F-44000 Nantes
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ALK-Abelló A/S Identifier: NCT01433510     History of Changes
Other Study ID Numbers: GT-15
2007-003772-20 ( EudraCT Number )
Study First Received: September 12, 2011
Last Updated: September 13, 2011

Keywords provided by ALK-Abelló A/S:

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases processed this record on September 20, 2017