NCT01830673

Regulatory T-cells After Subcutaneous Immunotherapy

Investigation of T-regulatory Cells After Subcutaneous Immunotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 28 Years
• Healthy volunteers: Not accepted

Summary

The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical symptomes during the pollen season, Skin Prick test diamter \>4mm or RAST class II or higher) were included. The patients were allocated to three study groups: Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment) Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant grass pollen allergy without SCIT. The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the patients to record symptoms during the adjacent pollen season. A blood sample was drawn to analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5, IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).

Conditions

• Grass Pollen Allergy
• Specific Immunotherapy

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-07-01
• Completion: 2012-10-01
• First posted: 2013-04-12
• Last updated: 2014-07-25

Locations

1 site across 1 country: Germany