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

NCT ID: NCT00413556

Last Updated: 2008-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

ALK Grass tablet

Intervention Type BIOLOGICAL

2

Group Type PLACEBO_COMPARATOR

ALK Grass tablet

Intervention Type BIOLOGICAL

Interventions

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ALK Grass tablet

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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ALK-Abelló S.a.

Principal Investigators

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Pilar Rico, MD

Role: STUDY_CHAIR

Medical Director, ALK-Abello, S.A.

Locations

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Hospital Clinico San Carlos

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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GT-16

Identifier Type: -

Identifier Source: org_study_id

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