Trials / Completed
CompletedNCT00413556
Changes in the Immune Response and Skin Reactivity of Grass Pollen Allergic Patients Treated With ALK Grass Tablets
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- ALK-Abelló A/S · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALK Grass tablet |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2007-08-01
- Completion
- 2007-12-01
- First posted
- 2006-12-19
- Last updated
- 2008-03-06
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT00413556. Inclusion in this directory is not an endorsement.