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NCT01433510 Clinical Trial

Tolerability of Grazax in Patients With Hayfever in Real Life Settings

Allergic Rhinoconjunctivitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01433510
Other study ID # GT-15
Secondary ID 2007-003772-20
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2007
Est. completion date December 2010

Study information
Verified date May 2024
Source ALK-Abelló A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 628
Est. completion date December 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Grazax
1 tablet/day - pre and co-seasonal

Locations
Country Name City State
France Centre Hospitalier Universitaire Nantes

Sponsors (1)
Lead Sponsor Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events related to Grazax All adverse events were reported according to the MedDRA dictionary From November 2007 to October 2010 (3 years)
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