A Trial of Grazax in Subjects With Hayfever

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Drug: Grazax

Study type: Interventional

Funder types: Industry

Identifiers

NCT00421655

GT-14

Details and patient eligibility

About

The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.

Enrollment: 329 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• History of grass pollen allergy
• Positive skin prick test to grass
• Positive specific IgE to grass

Exclusion Criteria

• FEV1 <70% of predicted value

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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329 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Grazax

2

Placebo Comparator group

Treatment:

Drug: Grazax