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

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413556
• Other study ID #: GT-16
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2006
• Last updated: March 4, 2008
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2008
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• ALK Grass tablet

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in serum leves of IgG4		6 months	No
Secondary	Changes in IgE level		6 months	No
Secondary	Changes in cutaneous response		6 months	No