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

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. Identifier: NCT01433510
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 14, 2011
Information provided by (Responsible Party):
ALK-Abelló A/S

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

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Drug: Grazax Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 628 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: Grazax Tablets 75000 SQT
Timothy Extract
Drug: Grazax
1 tablet/day - pre and co-seasonal

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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 identifier (NCT number): NCT01433510

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ALK-Abelló A/S Identifier: NCT01433510    
Other Study ID Numbers: GT-15
2007-003772-20 ( EudraCT Number )
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011
Keywords provided by ALK-Abelló A/S:
Additional relevant MeSH terms:
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Conjunctival Diseases
Eye Diseases