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

ALK-Abelló

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinoconjunctivitis

Treatments: Drug: Grazax

Study type: Interventional

Funder types: Industry

Identifiers

NCT01433510

GT-15

2007-003772-20 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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

Enrollment: 628 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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628 participants in 1 patient group

Grazax Tablets 75000 SQT

Experimental group

Description:

Timothy Extract

Treatment:

Drug: Grazax