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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413556
First Posted: December 19, 2006
Last Update Posted: March 6, 2008
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.
Information provided by:
ALK-Abelló A/S
  Purpose

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

  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00413556


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

Responsible Party: Pilar Rico Nieto - Medical Department, ALK-Abelló S.a.
ClinicalTrials.gov Identifier: NCT00413556     History of Changes
Other Study ID Numbers: GT-16
First Submitted: December 18, 2006
First Posted: December 19, 2006
Last Update Posted: March 6, 2008
Last Verified: March 2008

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