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

NCT00413556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2008-03-06

No results posted yet for this study

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.

Conditions

  • Allergy

Interventions

BIOLOGICAL

ALK Grass tablet

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • Pilar Rico, MD · Medical Director, ALK-Abello, S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-08-31
Completion
2007-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00413556 on ClinicalTrials.gov