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

Tracking Information
First Submitted Date  ICMJE September 12, 2011
First Posted Date  ICMJE September 14, 2011
Last Update Posted Date September 14, 2011
Study Start Date  ICMJE November 2007
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerability of Grazax in Patients With Hayfever in Real Life Settings
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinoconjunctivitis
Intervention  ICMJE Drug: Grazax
1 tablet/day - pre and co-seasonal
Study Arms  ICMJE Experimental: Grazax Tablets 75000 SQT
Timothy Extract
Intervention: Drug: Grazax
Publications * Wessel F, Chartier A, Meunier JP, Magnan A. Safety and tolerability of an SQ-standardized GRAss ALlergy immunotherapy tablet (GRAZAX®) in a real-life setting for three consecutive seasons - the GRAAL trial. Clin Drug Investig. 2012 Jul 1;32(7):451-63. doi: 10.2165/11634270-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2011)
628
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01433510
Other Study ID Numbers  ICMJE GT-15
2007-003772-20 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ALK-Abelló A/S
Study Sponsor  ICMJE ALK-Abelló A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: François FW Wessel, MD Centre Hospitalier Universitaire F-44000 Nantes
PRS Account ALK-Abelló A/S
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP