Changes in the Immune Response and Skin Reactivity of Grass Pollen Allergic Patients Treated With ALK Grass Tablets

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Biological: ALK Grass tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00413556

GT-16

Details and patient eligibility

About

We plan to determine changes in the immune system during the allergic response to grass pollen allergens. We have chosen a particular element of the immune response, the immunoglobulin G4 (IgG4) as an indicator.

We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE mediated) and late (cell mediated) allergic response.

Enrollment: 76 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Treatment with anti-IgE

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Biological: ALK Grass tablet

2

Placebo Comparator group

Treatment:

Biological: ALK Grass tablet