Back to resultsTolerability of Grazax in Patients With Hayfever in Real Life Settings (GRAAL)
Primary Purpose
Allergic Rhinoconjunctivitis
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Grazax
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring Allergic, Rhinoconjunctivitis, Immunotherapy
Eligibility 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)
Sites / Locations
- Centre Hospitalier Universitaire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Grazax Tablets 75000 SQT
Arm Description
Timothy Extract
Outcomes
Primary Outcome Measures
Adverse Events related to Grazax
All adverse events were reported according to the MedDRA dictionary
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01433510
Brief Title
Tolerability of Grazax in Patients With Hayfever in Real Life Settings
Acronym
GRAAL
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 Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis
Keywords
Allergic, Rhinoconjunctivitis, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
628 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Grazax Tablets 75000 SQT
Arm Type
Experimental
Arm Description
Timothy Extract
Intervention Type
Drug
Intervention Name(s)
Grazax
Intervention Description
1 tablet/day - pre and co-seasonal
Primary Outcome Measure Information:
Title
Adverse Events related to Grazax
Description
All adverse events were reported according to the MedDRA dictionary
Time Frame
From November 2007 to October 2010 (3 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François FW Wessel, MD
Organizational Affiliation
Centre Hospitalier Universitaire F-44000 Nantes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22594491
Citation
Wessel F, Chartier A, Meunier JP, Magnan A. Safety and tolerability of an SQ-standardized GRAss ALlergy immunotherapy tablet (GRAZAX(R)) 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.
Results Reference
derived
Learn more about this trial
Tolerability of Grazax in Patients With Hayfever in Real Life Settings
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