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

Phase 3

Completed

• Conditions: Allergy
• Interventions: Biological: ALK Grass tablet

• Registration Number: NCT00413556
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Study Start: 2007-01
• Primary Completion: 2007-08
• Study Completion: 2007-12
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-04
• Last Update Posted: 2008-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ALK Grass tablet	-
2	ALK Grass tablet	-

Primary Outcome Measures

Name	Time	Method
Difference in serum leves of IgG4	6 months

Secondary Outcome Measures

Name	Time	Method
Changes in IgE level	6 months
Changes in cutaneous response	6 months

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain