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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433510
First Posted: September 14, 2011
Last Update Posted: September 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ALK-Abelló A/S
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433510


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01433510     History of Changes
Other Study ID Numbers: GT-15
2007-003772-20 ( EudraCT Number )
First Submitted: September 12, 2011
First Posted: September 14, 2011
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by ALK-Abelló A/S:
Allergic
Rhinoconjunctivitis
Immunotherapy

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases