Clinical trial

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

Name

GT-15

Description

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

Trial arms

Trial start

2007-11-01

Estimated PCD

2010-10-01

Trial end

2010-12-01

Status

Completed

Phase

Early phase I

Treatment

Grazax

1 tablet/day - pre and co-seasonal

Arms:

Grazax Tablets 75000 SQT

Size

628

Primary endpoint

Adverse Events related to Grazax

From November 2007 to October 2010 (3 years)

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 628, 'type': 'ACTUAL'}}

Updated at

2024-05-29

1 organization

1 product

1 indication

Organization

ALK-Abelló

Product

Grazax

Indication

Allergic Rhinoconjunctivitis