Tolerability of Grazax in Patients With Hayfever in Real Life Settings

Phase 4

Completed

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Drug: Grazax

• Registration Number: NCT01433510
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Study First Submitted: 2011-09-12
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 628

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Grazax Tablets 75000 SQT	Grazax	Timothy Extract

Primary Outcome Measures

Name	Time	Method
Adverse Events related to Grazax	From November 2007 to October 2010 (3 years)	All adverse events were reported according to the MedDRA dictionary

Trial Locations

Locations (1)

Centre Hospitalier Universitaire; 🇫🇷 Nantes, France