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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01433510
First received: September 12, 2011
Last updated: September 13, 2011
Last verified: September 2011
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by ALK-Abelló A/S

Additional 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
Study First Received: September 12, 2011
Last Updated: September 13, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Conseil National de l'Ordre des Médecins
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

ClinicalTrials.gov processed this record on September 16, 2014