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

This study has been completed.
Information provided by:
ALK-Abelló A/S Identifier:
First received: December 18, 2006
Last updated: March 4, 2008
Last verified: March 2008

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.

Condition Intervention Phase
Allergy Biological: ALK Grass tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study Investigating Changes in Immunological Parameters and Cutaneous Reactivity Induced by a Short Course Immunotherapy With ALK Grass Tablets

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Difference in serum leves of IgG4 [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Changes in IgE level [ Time Frame: 6 months ]
  • Changes in cutaneous response [ Time Frame: 6 months ]

Enrollment: 76
Study Start Date: January 2007
Study Completion Date: December 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: ALK Grass tablet
Placebo Comparator: 2 Biological: ALK Grass tablet


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00413556

Hospital Clinico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
ALK-Abelló A/S
Study Chair: Pilar Rico, MD Medical Director, ALK-Abello, S.A.
  More Information

Responsible Party: Pilar Rico Nieto - Medical Department, ALK-Abelló S.a. Identifier: NCT00413556     History of Changes
Other Study ID Numbers: GT-16
Study First Received: December 18, 2006
Last Updated: March 4, 2008

Keywords provided by ALK-Abelló A/S:
Oral tablets
Ig G4
grass pollen
inmunotherapy processed this record on August 22, 2017