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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:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00413556
First received: December 18, 2006
Last updated: March 4, 2008
Last verified: March 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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

Primary Outcome Measures:
  • Difference in serum leves of IgG4 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in IgE level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in cutaneous response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 19, 2013