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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00413556
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : March 6, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Allergy Biological: ALK Grass tablet Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Active Comparator: 1 Biological: ALK Grass tablet
Placebo Comparator: 2 Biological: ALK Grass tablet

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

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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: Pilar Rico Nieto - Medical Department, ALK-Abelló S.a. Identifier: NCT00413556     History of Changes
Other Study ID Numbers: GT-16
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: March 6, 2008
Last Verified: March 2008

Keywords provided by ALK-Abelló A/S:
Oral tablets
Ig G4
grass pollen